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          Conditions of Use

          MEDICAL DEVICE REGULATION

          FIRST PART

          Purpose, Scope, Basis and Definitions

          Purpose and scope

          ARTICLE 1 -  (1) The purpose of this Regulation; The procedure for designing, classifying, producing, placing on the market, putting into service and inspecting the basic requirements that medical devices and accessories must meet and to ensure that patients, practitioners, users and third parties are protected against dangers that may arise in terms of health and safety during the use of these devices and accessories. and to regulate the principles.

          (2) This Regulation; It covers all activities of public institutions and organizations and real and legal persons related to the design, manufacture, market, putting into service, use and inspection of medical devices and accessories.

          (3) If a device is manufactured for the purpose of the application of a medicinal product covered by the Human Medicinal Products Licensing Regulation published in the Official Gazette dated 19/1/2005 and numbered 25705, the said device is considered within the scope of this Regulation. This situation does not prevent the application of the provisions of the Regulations for Human Medicinal Products Registration for the medicinal product.

          (4) If a device is placed on the market as a single product in combination with a medicinal product and is for single use, this single product is subject to the provisions of the Regulations on Registration of Medicinal Products for Human Use. In this case, as far as the safety and performance issues of the medical device are concerned, the provisions set out in Annex I of this Regulation regarding the basic requirements are applied.

          (5) If the device is used in integration with a substance in order to help its function on the human body and this substance is considered as a medical product within the scope of the Regulations on the Registration of Medicinal Products for Human Use, the device in question is considered within the scope of this Regulation.

          (6) If the device is used in integration with a substance in order to assist its function on the human body and this substance is used independently of the device, it is accepted as a medicinal product (human blood derivative) obtained from human blood or plasma within the scope of the Regulations on Registration of Medicinal Products for Human Use. the device in question is evaluated within the scope of this Regulation.

          (7) This Regulation;

          a) In vitro diagnostic medical devices,

          b) Active implantable medical devices covered by the Implantable Active Medical Devices Regulation published in the Official Gazette dated 9/1/2007 and numbered 26398,

          c) Medicinal products covered by the Regulations on Human Medicinal Products Registration published in the Official Gazette dated 19/1/2005 and numbered 25705,

          ç) Cosmetic products within the scope of the Cosmetics Law dated 24/3/2005 and numbered 5324,

          d) Except for human blood derivatives; Human blood, blood products, human plasma or blood cells and human cell, tissue, transplant organs or products made from these,

          e) Tissues and cells of animal origin, except for inactive animal tissues and medical devices containing products made from non-living animal tissues.

          does not apply.

          (8) When deciding whether a product is within the scope of the Registration Regulation for Medicinal Products for Human Use or this Regulation, the essential function of the product is examined.

          (9) When it is intended to be used by a device manufacturer in accordance with both this Regulation and the Personal Protective Equipment Regulation published in the Official Gazette dated 29/11/2006 and numbered 26361, the basic health and safety requirements in both regulations are also fulfilled.

          (10) The provisions of the Electromagnetic Compatibility Regulation published in the Official Gazette dated 24/10/2007 and numbered 26680 are not required for devices subject to conformity assessment within the scope of this Regulation.

          (11) The provisions of this Regulation do not affect the implementation of regulations regarding radiation safety and medical irradiation.

          Rest

          ARTICLE 2 -  (1) This Regulation; 4703 dated 29/6/2001 and numbered 4703 on the Preparation and Implementation of Technical Legislation on Products, the first paragraph of Article 3 of the Health Services Fundamental Law No. 3359 dated 7/5/1987 and the first paragraph of the 9th paragraph (c) Article 43 of the Decree Law on the Organization and Duties of the Ministry of Health, dated 13/12/1983 and numbered 181.

          Definitions

          ARTICLE 3 -  (1) In this Regulation;

          a) Accessory: The part or parts that are not considered a medical device in itself, but that are manufactured to be used with this device in order to ensure that the medical device is used for its purpose,

          b) Ministry: Ministry of Health,

          c) Device sub-category: Medical devices with common use purposes or common technologies,

          ç) Putting into service: Making a medical device ready for the end user for the first time in the market in accordance with its intended use,

          d) Custom-made device: Except for medical devices that are subject to mass production and adapted according to the wishes of the medical practitioner; Medical device with certain design features and for use in a particular patient, manufactured according to a prescription issued by a qualified medical practitioner,

          e) Manufacturer: Except for those who make medical devices available in the market suitable for their patients and prepare them for use in accordance with this Regulation, regardless of whether it is made by himself or a third person on his behalf, a medical device is designed, manufactured, before placing it on the market under its own name. the natural or legal person who packs, packs and labels; also a natural or legal person who brings together, packs, processes, completely renews and / or labels one or more ready-made products and / or puts them on the market as a medical device under his own name and in line with the intended use,

          f) Human blood derivative: Substances derived from human blood or plasma that, when used separately from the medical device, can be considered as a blood product component or blood product expressed in the Regulations for the Registration of Medicinal Products for Human Use and that help the effect of the medical device on the human body,

          g) In vitro diagnostic medical device: Essentially by the manufacturer;

          1) To obtain information about the physiological or pathological condition or

          2) To get information about congenital anomalies or

          3) To determine suitability and safety for prospective buyers, or

          4) monitoring the treatment

          All medical devices that are reagents, reagent products, calibrators, control materials, kits, instruments, equipment or systems designed for in vitro examination of samples taken from the human body, including blood and tissue donations, whether used alone or in combination for the purpose of Vacuum or non-vacuum sample containers used for preserving samples,

          ğ) Generic device group: Medical devices that have the same or similar uses or common technology, are classified as generics and do not show specific features,

          h) Law: Law No. 4703 on Preparation and Implementation of Technical Legislation on Products,

          ı) Clinical research device: The device or devices subject to clinical investigation to be carried out by a qualified medical practitioner or a person authorized to conduct clinical research on a human being in an adequate clinical environment in accordance with section (2.1) of Annex X,

          i) Clinical data: As a result of the use of a device;

          1) Clinical trials on the device in question, or

          2) From clinical trials or other studies in the scientific literature regarding a similar device whose equivalence to this device can be demonstrated, or

          3) From published and / or unpublished reports regarding the device in question or other clinical experience with a similar device that can be demonstrated equivalence to this device.

          Security and / or performance information obtained,

          j) Commission: European Union Commission,

          k) Purpose of use: The purpose of use stated in detail in the technical file by the manufacturer and specified in the medical device's user manual, promotional material or label,

          l) Shoulder, knee and hip joint replacement devices: Excluding auxiliary components such as screws, nails, plates; A medical device that is a component of an implantable joint replacement system to fulfill the function of a natural shoulder, knee or hip joint,

          m) Placing on the market: Except for clinical research devices; activity carried out for the first time that a new or completely renewed medical device is placed in the market for distribution and / or use, with or without charge, after the manufacturing process is completed,

          n) Disposable device: A medical device to be used only once for a single patient,

          o) Medical device: When used in humans, it does not provide its essential function with pharmacological, immunological or metabolic effects, but can be supported by these effects while performing its function and on the human being;

          1) diagnosis, prevention, monitoring, treatment or mitigation of the disease or

          2) Diagnosis, monitoring, treatment, mitigation or relief of injury or disability or

          3) Investigating, changing or replacing an anatomical or physiological function, or

          4) birth control

          All kinds of tools, instruments, equipment, software, accessories, including software that are manufactured for use, can be used alone or in combination, manufactured by the manufacturer specifically for diagnostic and / or therapeutic purposes and required for the medical device to perform its intended function or other materials,

          b) Authorized representative: which has been authorized by the manufacturer as an open and that can be addressed by acting on behalf of manufacturers and institutions and organizations in order to fulfill the obligations set out in this Regulation to natural or legal persons resident in Turkey,

          expresses.

          SECOND PART

          Supply to the Market and Putting into Service, Basic Requirements, Free Movement,

          Special Purpose Devices, Compliance with Harmonized Standards

          and Protection-Related Measures

          Placing on the market and putting into service

          ARTICLE 4 -  (1) Medical devices that meet the provisions of this Regulation are provided to the market or put into service when duly procured, installed, maintained, maintained and used in accordance with its purpose.

          Basic requirements

          ARTICLE 5 -  (1) Medical devices and accessories must comply with the basic requirements specified in Annex I, taking into account the intended use.

          (2) In cases where the devices covered by this Regulation are also covered by the Machinery Safety Regulation published in the Official Gazette dated 3/3/2009 and numbered 27158, the specific basic requirements of the said Regulation regarding health and safety must also be met.

          Free roaming, special purpose devices

          ARTICLE 6 -  (1) Medical devices that are subjected to conformity assessment procedures and affixed with the CE mark in accordance with the provisions of this Regulation are not prevented from being placed on the market or brought into service.

          (2) CE mark cannot be affixed to the following devices and no obstacle is placed for these situations:

          a) The use of clinical research devices that comply with the conditions specified in Article 15 and Annex VIII by a medical practitioner or a person authorized to conduct a clinical trial,

          b) The placing on the market and putting into service of Class IIa, IIb and III medical devices which are made available to a particular patient with the name or identification number, and bespoke medical devices in accordance with the provisions of this Regulation, provided that they have the declaration stated in Annex VIII.

          (3) Medical devices that do not comply with the provisions of this Regulation cannot be prevented from displaying in places such as trade fairs and exhibitions, provided that they bear a sign clearly indicating that they cannot be placed on the market and put into service until the provisions of the Regulation are fulfilled.

          (4) The information, user manuals, labels, maintenance-repair booklet and other explanations specified in Part (13) of Annex I, which should be provided by the manufacturer with the medical device for patients, users and practitioners, should be in Turkish when the medical device is placed on the market.

          Compliance with harmonized standards

          ARTICLE 7 -  (1) Medical devices manufactured in accordance with the harmonized standards published by the European Union are deemed to meet the relevant provisions of the basic requirements specified in Article 5.

          (2) Compliance with harmonized standards, in particular;

          a) In the interaction between the materials used and medical products in medical devices containing medicinal products,

          b) In surgical threads,

          Includes European Pharmacopoeia monographs.

          (3) If it is determined that the harmonized standards do not fully meet the basic requirements, the situation is notified to the Ministry. The Ministry transmits this information to the Commission through the Undersecretariat of Foreign Trade or electronically.

          Protection measures

          ARTICLE 8 -  (1) The Ministry, except for the clinical research devices specified in the clause (a) of the second paragraph of Article 6; When it is determined that the use of medical devices installed, used and maintained in accordance with the purpose of use poses a danger to the health and / or safety of the patient, user, practitioner or third parties, to ensure that these devices are withdrawn from the market, to prevent or restrict their introduction to the market, to prevent or restrict their introduction takes all necessary measures. It submits its reasoned decision regarding this issue and its opinion on whether the nonconformity regarding the medical device arises from the following issues to the Commission through the Undersecretariat of Foreign Trade or electronically.

          a) Failure to meet the basic requirements in Article 5,

          b) Incorrect application of the standards in article 7,

          c) Deficiencies caused by the standards themselves.

          (2) When a medical device that does not comply with this Regulation bears the CE mark, the Ministry takes the necessary measures against those who attach the mark and informs the Commission through the Undersecretariat of Foreign Trade or electronically.

          THIRD PART

          Classification, Warning System, Conformity Assessment Procedures,

          Systems, Process Packages and Special Methods for Sterilization

          and Exception Notifications

          Classification

          ARTICLE 9 -  (1) Medical devices are divided into four classes as Class I, IIa, IIb and III according to the principles specified in Annex IX.

          (2) The disputes that may arise between the manufacturer and the notified body regarding the application of the classification rules are forwarded by the parties to the competent authority that appointed the notified body.

          (3) When the Ministry considers it necessary to rearrange the classification rules specified in Annex IX in the light of the information obtained from the negativities evaluated within the scope of Article 10 or technical developments after the medical device is placed on the market, it shall forward its justified request to the Commission via the Undersecretariat of Foreign Trade or electronically.

          Warning system

          ARTICLE 10 -  (1) The Ministry ensures that the following information submitted to it within the framework of the provisions of this Regulation on Class I, IIa, IIb or III medical devices are recorded, evaluated and the necessary measures are taken. This information is:

          a) Has caused or caused serious deterioration in the health status of the patient or the user or death;

          1) Deterioration or deviation of the characteristics and / or performance of the medical device,

          2) The deficiencies in the user manual and label,

          b) Technical and medical reasons depending on the characteristics and performance of the medical device that cause the systematic withdrawal from the market by the manufacturer of the same type of medical devices due to the reasons specified in paragraph (a) of this paragraph.

          (2) The Ministry is immediately informed by the relevant health personnel and / or health institution about the situations specified in the first paragraph. The Ministry informs the manufacturer or his authorized representative about the incident in order to ensure that the necessary measures are taken.

          (3) The Ministry, after making the necessary evaluations together with the manufacturer or authorized representative, if possible, without prejudice to the matters in article 8, about the adverse events specified in the first paragraph of this article and the measures taken or anticipated to be taken to minimize the possibility of their recurrence. It informs the Commission immediately through the Undersecretariat of Foreign Trade or electronically.

          Conformity assessment procedures

          ARTICLE 11 -  (1) The issues specified in this article are taken into account in conformity assessment procedures.

          (2) Except for custom-made devices and clinical research devices; The manufacturer only follows the procedure set out in Annex VII to affix the CE marking to Class I medical devices and issues the declaration of conformity in this appendix.

          (3) Except for custom-made devices and clinical research devices; the manufacturer, to affix the CE marking to Class IIa medical devices;

          a) the declaration of conformity process for the full quality assurance system [excluding part (4)] as specified in Annex II, or

          b) Together with the declaration of conformity process specified in Annex VII;

          1) Verification specified in Annex IV, or

          2) Production quality assurance specified in Annex V or

          3) Follows the declaration of conformity process regarding product quality assurance specified in Annex VI.

          (4) Except for custom-made devices and clinical research devices; the manufacturer, to affix the CE marking to Class IIb medical devices;

          a) the declaration of conformity process for the full quality assurance system [excluding part (4)] as specified in Annex II, or

          b) Along with the type examination specified in Annex III;

          1) Verification specified in Annex IV, or

          2) Production quality assurance specified in Annex V or

          3) Follows the declaration of conformity process regarding product quality assurance specified in Annex VI.

          (5) Excluding custom-made devices and clinical research devices; the manufacturer, to affix the CE marking to Class III medical devices;

          a) the declaration of conformity process regarding the full quality assurance system specified in Annex II; or

          b) With the type examination specified in Annex III;

          1) Verification specified in Annex IV, or

          2) Follows the declaration of conformity process regarding production quality assurance specified in Annex V.

          (6) For bespoke devices, the manufacturer issues the declaration in this Annex, following the procedure set out in Annex VIII before placing each device on the market. It sends a list of custom-made devices that are put into service to the Ministry.

          (7) The manufacturer and / or notified body takes into account the evaluation and verification results made at the intermediate stage of production in accordance with this Regulation during the conformity assessment procedures of the medical device.

          (8) The manufacturer may assign its authorized representative to initiate the procedures specified in Annex III, IV, VII and VIII.

          (9) In cases where the notified body should be involved in the conformity assessment process, the manufacturer or its authorized representative selects one of the notified bodies for this work.

          (10) The notified body requests all kinds of information and documents from the applicant to confirm compliance within the framework of the selected transaction.

          (11) Decisions taken by notified bodies in accordance with Annex II, III, V and VI are valid for a maximum of 5 (five) years. However, upon the application made within the period specified in the contract signed between the notified body and the manufacturer, the validity period of the decision may be extended for a maximum of 5 (five) years.

          (12) Records and correspondence regarding the methods specified in the second, third, fourth, fifth and sixth paragraphs shall be made in Turkish and / or one of the official languages ​​of the European Union accepted by the notified body.

          (13) The Ministry may permit, upon a justified request, the placing on the market and put into service within the borders of the country of individual medical devices that are determined to help protect health when used, but that the procedures specified in the second, third, fourth, fifth and sixth paragraphs are not applied.

          Systems, process packages and special methods for sterilization

          ARTICLE 12 -  (1) The provisions of this article shall apply when medical devices affixed with the CE mark within the framework of the provisions of Article 11 are brought together as a transaction package or device system for the purpose of placing on the market. All real and legal persons performing this transaction;

          a) Medical devices that are brought together in accordance with the manufacturer's instructions, medical devices are mutually compatible and the assembly process is carried out according to these instructions,

          b) When placing a process package or device system on the market, user manuals in accordance with the manufacturer's instructions are made available to users,

          c) Internal controls and inspections of this entire process are carried out with appropriate methods, 

          issues a transaction package or device system statement indicating.

          (2) In the event that the conditions specified in the first paragraph of this article are not fulfilled, if a process package or device system is combined with devices that do not have CE marking, or if the selected device combination is not compatible with the actual use, these device combinations shall be treated as a single medical device and provisions apply.

          (3) In the sterilization process;

           a) Natural or legal persons who sterilize medical devices designed to be sterilized before use, in order to put them on the market, follow one of the procedures in Annex II or Annex V.

          b) In procedures related to sterility, the application of Annex II or Annex V with the intervention of the notified body is until the sterile package is opened or damaged.

          c) Real or legal persons prepare a declaration stating that they have performed the sterilization process in accordance with the manufacturer's instructions.

          (4) Medical devices specified in the first and third paragraphs do not carry an additional CE mark. These devices carry the information provided by their manufacturer and specified in Annex I / 13. The statements specified in the first and third paragraphs are kept for 5 (five) years to be submitted to the Ministry.

          Notifications regarding classification and exceptions

          ARTICLE 13 -  (1) The Ministry;

          a) When there is hesitation and a decision needs to be made during the application of the classification rules specified in Annex IX to a particular medical device or group of medical devices;

          b) When a medical device or group of medical devices is to be evaluated in another class, with the exception of Annex IX provisions; 

          c) When the suitability of the medical device or the medical device group is to be ensured by applying only one of the methods specified in the article, with the exception of the provisions of article 11;

          ç) When it is necessary to make a decision regarding whether a certain product or group of products falls under any of the definitions in subparagraphs (a), (d), (g), (ı) or (o) of the first paragraph of Article 3;

          it submits its request to the Commission via the Undersecretariat of Foreign Trade or electronically in order to take the necessary measures together with its justifications.

          SECTION FOUR

          Registration System, Clinical Trials, Notified Body and CE Marking

          Recording system

          ARTICLE 14 -  (1) The Ministry keeps records of the medical devices placed on the market according to the principles specified in this article and the persons responsible for placing these devices on the market.

          (2) The manufacturer who puts the medical device on the market under its own name in accordance with the procedures specified in the second, third, fourth, fifth and sixth paragraphs of Article 11, and the real or legal person engaged in the activities specified in Article 12, the necessary information and documents regarding the enterprise and the medical device. notifies.

          (3) When Class IIa, IIb and III medical devices are placed on the market, the Ministry requests information about the device along with the label and user manual of the medical devices.

          (4) If the manufacturer that places the medical device on the market under its own name is outside the borders of the country, its authorized representative is notified to the Ministry. The authorized representative notifies the Ministry of the company addresses registered within the borders of the country and the said information regarding the medical devices specified in the second paragraph.

          (5) The Ministry shall notify the information submitted by the manufacturer or the authorized representative regarding the medical devices in the third paragraph to the Commission, if requested, through the Undersecretariat of Foreign Trade or electronically and request information from the Commission when necessary.

          (6) The regulatory data related to this Regulation are stored in the medical device database in order to ensure that the competent institutions fulfill their duties within the framework of this Regulation. The database consists of the following elements:

          (a) Data on the records of manufacturers, authorized representatives and medical devices specified in the third paragraph of this article,

          (b) data on documents submitted, amended, supplemented, suspended, withdrawn or rejected in accordance with the method provided for in Annexes II, III, IV, V, VI and VII;

          (c) Data obtained through the warning system regulated in Article 10,

          (ç) Data on clinical trials regulated in Article 15.

          (7) The Ministry takes all necessary measures when it is necessary to prohibit, restrict or subject a certain medical device or group of medical devices to withdraw from the market or to put them into service, in order to protect health and safety and / or observe public health requirements. In this case, it notifies the Commission of its justified decision through the Undersecretariat of Foreign Trade or electronically.

          Clinical trials

          ARTICLE 15 -  (1) The manufacturer or authorized representative performs the procedures specified in Annex VIII for devices for clinical research and submits the necessary information about the clinical trial to the Ministry together with the statement in Part 2.2 of Annex VIII.

          (2) The manufacturer notifies the Ministry of clinical research request for Class III medical devices, implants and long-term invasive devices included in Class IIa or IIb, with the approval of the relevant Ethics Committee. The Ministry finalizes the clinical trial request 60 (sixty) days after the notification date.

          (3) If the relevant Ethics Committee gives a positive opinion by adding its own justification to the research plan, the Ministry may give permission to the manufacturer to initiate the clinical trial without waiting for the 60 (sixty) day period to expire.

          (4) In the case of medical devices other than the devices specified in the second paragraph, if the relevant Ethics Committee gives a positive opinion by adding its own justification to the research plan, the Ministry may permit manufacturers to immediately initiate clinical trials.

          (5) Clinical trials are conducted according to the provisions specified in Annex X.

          (6) When necessary, the Ministry takes necessary and appropriate measures to protect public health and public interest in terms of clinical trials. When the Ministry refuses, suspends, temporarily suspends or requests an important change in a clinical trial, it notifies the said decision with its justification to the Commission via the Undersecretariat of Foreign Trade or electronically.

          (7) The manufacturer or authorized representative informs the Ministry regarding the result of the clinical trial. In case of premature termination of the clinical trial, the justification is also reported. In cases where early termination is made for security reasons, the Ministry notifies the Commission about the situation via the Undersecretariat of Foreign Trade or electronically. The report specified in Annex X / 2.3.7 is made available by the manufacturer or authorized representative to be submitted to the Ministry.

          (8) If the clinical trial is conducted using medical devices bearing the CE mark for the purpose specified in the conformity assessment procedures of the medical device, only the relevant provisions of Annex X shall apply for this.

          Notified body

          ARTICLE 16 -  (1) Organizations that can fulfill the duties specified in Article 11 and the special duties assigned to them apply to the Ministry. The Ministry evaluates the notified body candidates in line with the issues specified in this article and sends those found appropriate to the Undersecretariat of Foreign Trade to be notified to the Commission. After the identification number is given by the commission, the decision of the Ministry on the appointment of a notified body is published in the Official Gazette and the notified body starts its activities.

          (2) Compliance with the requirements specified in Annex XI is sought in determining notified bodies. In addition, the provisions of the Law and the Regulation on Conformity Assessment Bodies and Notified Bodies published in the Official Gazette dated 17/1/2002 and numbered 24643 are also applied. In addition, organizations that meet harmonized standards for notified bodies are considered to meet the requirements in Annex XI.

          (3) Upon request, the notified body submits to the Ministry all information and documents that will enable the inspection of compliance with the conditions stipulated in Annex XI, including budget documents.

          (4) If the Ministry determines that the notified body does not comply with the conditions specified in the second paragraph; It cancels the approval and publishes this decision in the Official Gazette. It also conveys it to the Undersecretariat of Foreign Trade to be notified to the Commission.

          (5) The notified body and the manufacturer or authorized representative jointly determine the time required for the completion of the evaluation and verification procedures in Annex II, III, IV, V and VI.

          (6) The notified body informs the Ministry about all documents it has issued, amended, supplemented, suspended, canceled or withdrawn. It also informs other notified bodies operating within the scope of this Regulation about these issues and, if requested, the documents it issues. The notified body also provides all additional information requested from it.

          (7) When the notified body determines that the relevant provisions of this Regulation have not been complied with by the manufacturer or the certificate has been given inadvertently; It suspends, cancels or is subject to restrictions, taking into account the principle of proportionality, the certificate issued until the corrective measures are taken by the manufacturer and compliance with the relevant requirements. In these cases, or where the Ministry's intervention is deemed necessary, the notified body informs the Ministry. The Ministry notifies this matter to the Commission through the Undersecretariat of Foreign Trade or electronically.

          CE marking

          ARTICLE 17 -  (1) The following points are taken into account in the affixing of the CE mark:

          a) When placed on the market, all medical devices other than custom-made devices and clinical research devices must bear the CE mark together with the identification number of the notified body responsible for the implementation of the procedures specified in Annex II, IV, V and VI.

          b) The CE mark specified in Annex XII is affixed to the medical device in an easily visible, legible and indelible manner, on its sterile packaging, user manual and sales package.

          c) It is forbidden to attach signs or phrases that may cause misunderstanding about the meaning or shape of the CE mark. Another mark can only be placed on the medical device, on its packaging or in the user manual so that the CE mark cannot be seen and read.

          (2) In addition, regarding the attachment and use of the CE mark, it is obligatory to comply with the Law and the provisions of the Regulation on the Attachment and Use of the "CE" Mark of Conformity published in the Official Gazette dated 17/1/2002 and numbered 24643.

          CE marking improperly attached

          ARTICLE 18 -  (1) In case it is determined that the CE mark is attached to the medical device illegally or not at all, without prejudice to the provisions of Article 8; The manufacturer or his authorized representative must end the violation within the framework of the conditions determined by the Ministry. In the event of the violation, the Ministry takes all necessary measures to restrict or prohibit the placing of the medical device on the market and ensures that the medical device is withdrawn from the market.

          (2) Although not covered by this Regulation, the provisions of the first paragraph are also applied to the products affixed with the CE mark according to the provisions of this Regulation.

          FIFTH SECTION

          Miscellaneous Provisions

          Refusal or restriction decisions

          ARTICLE 19 -  (1) During the implementation of this Regulation by the Ministry,

          a) Decisions taken as rejection or restrictive for placing the medical device on the market, putting it into service or clinical trials,

          b) Decisions regarding the withdrawal of medical devices from the market,

          are clearly stated together with the reasons.

          (2) For all decisions specified in the first paragraph, if it is possible according to the urgency of the measure to be taken, the manufacturer or the authorized representative has the right to express his opinion in advance.

          (3) Regarding the rejection or restriction or withdrawal from the market regarding the medical device (s), the Law and the Procedure and Procedure for the Market Surveillance and Inspection by the Ministry of Health published in the Official Gazette dated 25/6/2007 and numbered 26563. The provisions of the Regulation on the Principles are also applied.

          Privacy

          ARTICLE 20 -  (1) The Ministry, the notified body and all parties participating in the implementation of this Regulation ensure the confidentiality of all information they provide while performing their duties. However, the Ministry's obligations under the mutual information sharing and warning system with other national authorities and notified bodies are reserved. In addition, these confidential information may be disclosed by informing the Ministry, upon the request of the judicial and relevant higher authorities, in cases required by the public health and order.

          (2) The following issues are not considered within the scope of confidentiality:

          a) Registration information of persons responsible for placing medical devices on the market pursuant to Article 14,

          b) Information sent to users by the manufacturer, authorized representative or distributor in accordance with the measures specified in the third paragraph of Article 10,

          c) Information included in the issued, corrected, supplemented, suspended or revoked certificates.

          Advisory commissions

          ARTICLE 21 -  (1) The Ministry may establish new advisory commissions when the technical regulations and advisory commissions within its body are insufficient on medical devices and standards. Establishment of advisory commissions, their working principles and procedures, and their duties, powers and responsibilities are determined by the Directive to be issued by the Ministry.

          Compliance with other legislation

          ARTICLE 22 -  (1) If the medical device is subject to other legislation stipulating the attachment of the CE mark, it must comply with the provisions of other relevant legislation.

          (2) If one or more of the other relevant legislation gives the manufacturer the choice of application during a transitional period, the CE mark only shows compliance with the provisions of the legislation that the manufacturer has chosen to apply. In this case, which legislation is applied is stated in the documents, warnings, label or user manual provided with the medical device.

          SIXTH SECTION

          Final Provisions

          Safety of use

          ARTICLE 23 -  (1) Medical devices are used in accordance with the purpose of use stipulated by the manufacturer and the recommendations specified in the user manual, if any.

          (2) In medical devices that require installation, quality control tests, calibration or maintenance-repair, the aforementioned procedures are carried out as prescribed by the manufacturer.

          (3) In order to ensure the safe use of medical devices, necessary trainings are carried out by taking into account the issues stipulated by the manufacturer.

          Provisions to be applied on contravention

          ARTICLE 24 -  (1) The provisions of the Law, Turkish Penal Code No.5237 and dated 26/9/2004 and other relevant legislation are applied to those who act and act in violation of the provisions of this Regulation.

          Harmonized European Union legislation

          ARTICLE 25 -  (1) This Regulation, in order to comply with the legislation of the European Union on medical devices;

          a) Medical Devices Directive 93/42 / EEC,

          b) Directive 98/79 / EC on In Vitro Medical Diagnostic Devices,

          c) The Directive 2000/70 / EC on Medical Devices Containing Stable Derivatives of Human Blood or Plasma,

          ç) Directive 2001/104 / EC on the amendment of the Medical Device Directive No. 93/42 / EEC,

          d) Commission Directive 2003/12 / EC on the reclassification of breast implants within the framework of the Medical Device Directive 93/42 / EEC,

          e) Commission Directive 2005/50 / EC on the reclassification of shoulder, knee and hip joint replacement devices within the framework of the Medical Device Directive 93/42 / EEC,

          f) Directive 2007/47 / EC amending the Directive 90/385 / EEC on Active Implantable Medical Devices, the Medical Devices Directive 93/42 / EEC and the Directive on the Market Placement of Biocidal Products 98/8 / EC.

          It was prepared in parallel.

          Citations

          ARTICLE 26 -  (1) References made to the Medical Device Regulation previously published in the Official Gazette dated 9/1/2007 and numbered 26398 in other regulations are deemed to have been made to this Regulation.

          The abolished regulation

          ARTICLE 27 -  (1) The Medical Device Regulation published in the Official Gazette dated 9/1/2007 and numbered 26398 has been repealed.

          Force

          ARTICLE 28 -  (1) This Regulation enters into force on the date of its publication.

          Executive

          ARTICLE 29 -  (1) The provisions of this Regulation are executed by the Minister of Health.

          EK I

          BASIC REQUIREMENTS

          GENERAL REQUIREMENTS

          1) Medical devices should be designed and manufactured in a way that, when used in accordance with their intended use and conditions, they do not endanger the clinical condition or safety of patients, or the health or safety of users or other persons when necessary.

          The risks associated with the intended use of medical devices should be acceptable compared to their benefits to the patient, and should ensure a high level of health and safety protection.

          In the design of the medical device;

          - to reduce the risk of misuse that may arise from the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety) and

          - Considering the technical knowledge, experience, educational background and, if possible, medical and physical condition of the persons who are considered to use the device (design for professional, disabled or other users).

          2) The solutions adopted by the manufacturer in the design and construction of medical devices must include generally accepted technical methods and must comply with safety principles. The manufacturer should apply the following points in the selection of the most suitable solutions:

          - Safe design and production to reduce or eliminate hazards as much as possible,

          - If the dangers cannot be eliminated, necessary and sufficient protection measures such as an alarm should be taken,

          - In cases where the protection measures taken cannot completely eliminate the dangers, the remaining risks should be reported to the user.

          3) The medical device must reach the performance stipulated by the manufacturer and must be designed, manufactured and packaged in a manner that can comply with one or more of the functions specified in the clause (o) of the first paragraph of Article 3 of this Regulation.

          4) Problems that may arise during the use of the medical device under normal conditions during the period of use specified by the manufacturer; The characteristics of the medical device specified in sections (1), (2) and (3) of this Annex should not be of a nature that will alter the performance and clinical conditions, and impair the health and safety of the patient, the user and the third parties.

          5) Medical devices should be designed, manufactured and packaged in such a way that their characteristics and performance are not adversely affected during the prescribed use period when transported and stored in accordance with the information provided in the user manual provided by the manufacturer.

          6) The risk of unwanted side effects of the medical device should be acceptable compared to the performance expected from the medical device.

          6.a) Conformity of the medical device with the essential requirements should include a clinical assessment according to Annex X.

          II. DESIGN AND CONSTRUCTION REQUIREMENTS

          7) Chemical, physical and biological properties:

          7.1. Medical devices must be designed and manufactured in such a way as to guarantee the characteristics and performance specified in the "General Requirements" of this Annex, in particular taking into account the following points.

          - Especially toxicity and flammability in the selection of the material to be used,

          - Considering the purpose of use of medical devices, the compatibility between the material used and biological tissue, cell and body fluids,

          - Where required, previously validated biophysical or modeling research results.

          7.2. Medical devices; In accordance with the intended use, it should be designed, manufactured and packaged in a way that minimizes hazards in terms of residues and contaminants for patients, persons who use, maintain and transport the medical device. Particular attention should be paid to tissues exposed to the medical device, duration and frequency of exposure.

          7.3. Medical devices should be designed and manufactured in such a way that they can be used safely with the materials, substances and gases they come into contact with during their normal use or routine operations. If the medical device is intended to deliver a medical product, these devices must be designed and manufactured in accordance with the precautions and restrictions of the relevant products, and the performance of both must be maintained in accordance with the intended use.

          7.4. When used alone, a substance considered within the scope of a medicinal product included in the Registration Regulation for Medicinal Products for Human Use as a complementary part of the medical device supporting its function on the human body, the safety, quality and usefulness of this substance should be evaluated by comparing with the appropriate methods defined in the relevant Regulation. .

          Regarding the articles mentioned in the first paragraph; The notified body shall be informed by the Ministry or the European Medical Products Evaluation Agency regarding the clinical benefit / risk profile of the use in the device, considering whether the substance is beneficial to use as part of the medical device and considering the intended use of the device. (EMEA) applies to the scientific opinion it will give in accordance with the relevant legislation. In the said scientific opinion, the data prepared by the notified body regarding the manufacturing process and the benefit of adding this substance to the medical device are taken into consideration.

          If a medical device contains a human blood derivative as part of the whole, the notified body shall assess whether the substance is useful as part of the medical device and, taking into account the intended use of the device, whether the derivative is of good quality and safe and the clinical benefit of its use in the device. / asks for scientific opinion from the European Medicines Assessment Agency (EMEA) regarding the risk profile. In the said scientific opinion, the data prepared by the notified body regarding the manufacturing process and the benefit of using this substance in the medical device are taken into consideration.

          When changes are made to the supplementary materials in the medical device, in particular the manufacturing process, these changes are notified to the notified body. The notified body applies again to the Ministry or the European Medical Products Assessment Agency (EMEA), from which it previously consulted, in order to confirm that the quality and safety of these substances are maintained. In order to confirm that the changes made do not adversely affect the benefit / risk profile previously prepared for the substance in the medical device, the institution providing the opinion shall take into account the data prepared by the notified body regarding the benefit of adding the substance to the medical device.

          When the institution giving the opinion reaches the information that the supplementary substance in question may affect the current benefit / risk profile if used in the medical device, it informs the notified body about whether such an effect exists. The notified body takes into account the current scientific opinion in the evaluation of the conformity assessment process.

          7.5. Medical devices must be designed and manufactured in a way that minimizes the hazards that may be caused by substances leaking from them. According to the Regulation on Classification, Packaging and Labeling of Hazardous Substances and Preparations published in the Official Gazette dated 26/12/2008 and numbered 27092 Reiterated, special attention is given to substances that have carcinogenic, mutagenic or toxic effects on reproduction.

          Carcinogenic according to the Regulation on Classification, Packaging and Labeling of Hazardous Substances and Preparations of a part of a medical device or medical device intended to apply and / or remove drugs, body fluids or other substances from the body, or medical devices intended to transport and store such body fluids or substances. If it contains phthalates of categories 1 and 2, which are mutagenic or toxic to reproduction, a labeling should be made on the medical device and / or on the packaging of each part or on the sales package where necessary, indicating that the medical device contains phthalates.

          When the medical devices in question are intended to be used in the treatment of pregnant women, nursing women or children, the manufacturer shall include information on the specific justification of the use of such substances, in particular in terms of compliance with the basic requirements of this paragraph, and the risks to the patient groups in question and the appropriate precautionary measures, in the technical file and user manual. should give.

          7.6. The medical device should be designed and manufactured in a way that minimizes the dangers associated with unintentional substances, taking into account the environmental conditions in which it will be used.

          8) Infection and microbiological contamination:

          8.1. Medical devices and manufacturing processes; It should be designed in such a way that the risk of infection of the patient, practitioner and third parties is eliminated or as low as possible. The design should be easy to implement and, if necessary, minimize contamination of the patient from the medical device or from the patient during use.

          8.2. Tissues of animal origin should be obtained from animals that have undergone appropriate control and veterinary control for their intended use.

          Notified bodies must keep information on the geographic origin of animals.

          Processing, preservation, testing and use of cells and materials of animal origin should be carried out under the most appropriate safety conditions. Safety, especially with regard to viruses and other infectious agents, should be ensured by applying valid elimination or viral inactivation methods during the manufacturing process.

          8.3. When sterile medical devices are placed on the market in single-use packages, they should be designed, manufactured and packaged in accordance with appropriate methods to ensure that they remain sterile until the protective packaging is opened or damaged during storage and transportation.

          8.4. Sterile medical devices must be manufactured and sterilized using an appropriate and valid method.

          8.5. Medical devices that require sterilization must be duly manufactured in controlled environments (eg environmental conditions).

          8.6. Packaging systems of non-sterile medical devices; It should be in a manner that maintains the prescribed level of cleanliness without deterioration of the medical device, and minimizes the risk of microbiological contamination if medical devices are to be sterilized before use.

          The packaging system must be suitable for sterilization with the sterilization method specified by the manufacturer.

          8.7. The packaging and / or label of the medical device should be such that it distinguishes the same or similar medical devices sold non-sterile and sterile.

          9) Construction and environmental properties:

          9.1. If the medical device is to be used in combination with another medical device or equipment, the entire combination, including connection systems, should be safe and should not reduce the specified performance of that device. Restrictions for use should be stated on the label or user manual.

          9.2. The medical device should be designed and manufactured in such a way as to eliminate the following dangers or, where possible, to minimize them.

          - Risk of injury due to the physical characteristics of the medical device, including dimensional and ergonomic features and the volume / pressure ratio.

          - Hazards due to predicted environmental conditions such as magnetic field, external electrical effects, electrostatic discharge, pressure, temperature or acceleration and pressure changes.

          - Dangers of interaction with other medical devices normally used during applied therapy or clinical trials.

          - Hazards that arise in cases where maintenance or calibration is not possible (such as in implants) as a result of the loss of validity of any measurement or control mechanism or aging or wear of the material used.

          9.3. The medical device must be designed and manufactured in such a way that the risk of fire or explosion is minimized during normal use and even a simple error. Particular attention should be paid to these issues when the medical device needs to be used with flammable, explosive or flammable materials.

          10) Medical devices with measuring function:

          10.1. Medical devices with measurement function should be designed and manufactured in a way to ensure sufficient sensitivity and remain within the appropriate measurement sensitivity limits, taking into account the intended purpose of the medical device. Sensitivity limits should be determined by the manufacturer.

          10.2. Measuring, monitoring and indicator scale should be designed according to ergonomic principles, considering the purpose of use of the medical device.

          10.3. Measurements performed with a medical device with measurement function should be expressed in units of measure specified in the Regulation on the International System of Units published in the Official Gazette dated 21/6/2002 and numbered 24792.

          11) Protection against radiation:

          11.1. Generally:

          11.1.1. In the design and manufacture of medical devices; Necessary precautions should be taken to minimize the effect that may occur on patients, users and third parties exposed to radiation. However, the medical device must be designed and manufactured in such a way that it does not restrict the administration of appropriate doses specified for treatment and diagnosis.

          11.2. Radiation desired:

          11.2.1. When it comes to designing a medical device that emits hazardous levels of radiation for a specific medical purpose where the benefit provided by the emission outweighs the emission risks, the user should be given the opportunity to control the emission. These medical devices should be designed and manufactured to ensure tolerance and reproducibility of the relevant permanently variable parameters.

          11.2.2. When a medical device poses a potential radiation hazard that is visible and / or invisible, it must be equipped with visual and / or audible warning systems.

          11.3. Unwanted radiation:

          11.3.1. The medical device should be designed and manufactured in such a way as to minimize the exposure of patients, users and third parties to unwanted, deviating or fallout radiation emission as much as possible.

          11.4. User manuals:

          11.4.1. The user manuals of the medical devices that emit radiation should contain detailed information about the nature of the emitted radiation, the measures for the protection of the patient and the user, the ways to avoid misuse and the elimination of the dangers arising from the installation of the medical device.

          11.5. Ionizing radiation:

          11.5.1. Medical devices that emit ionizing radiation should be designed and manufactured in such a way that the quality, quantity and geometry of the emitted radiation can be regulated and controlled according to the intended use.

          11.5.2. Medical devices that emit ionizing radiation for radiodiagnostic purposes should be designed and manufactured in a way that minimizes the patient and user exposure to radiation, thereby ensuring the quality of the image and / or output suitable for the prescribed medical purpose.

          11.5.3. Medical devices that emit ionizing radiation for radiotherapy purposes should be designed and manufactured in such a way as to allow a reliable observation and control of the applied dose, the type and energy of the beam, and the quality of the beam when necessary.

          12) Requirements for medical devices equipped or associated with an energy source:

          12.1. Medical devices containing programmable electronic systems should be designed to ensure the continuity, reliability and performance of these systems in accordance with the foreseen use. The medical device must be equipped with appropriate means to minimize or eliminate potential dangers should any fault occur in the system.

          12.1.a. The software of medical devices that contain software or are medical software must comply with current technology, taking into account development stages, risk management, validation and verification principles.

          12.2. Where patient safety is dependent on an internal energy source, the medical device must be equipped with a device that indicates the status of the power supply.

          12.3. In cases where patient safety is dependent on an external energy source, the medical device must be equipped with an alarm system that signals in case of power failure.

          12.4. Medical devices intended to monitor one or more of the patient's clinical parameters should be equipped with appropriate alarm systems that alert the user in situations that could lead to the death of the patient or serious deterioration in health.

          12.5. Medical devices should be designed and manufactured in such a way that the risk of creating electromagnetic fields that may affect the operation of other medical devices or equipment in the same environment is minimized.

          12.6. Protection against electrical hazards:

          Correctly installed medical devices should be designed and manufactured in such a way that they do not pose a risk of electrical shock during normal use and even in the event of a simple error.

          12.7. Protection against mechanical and thermal hazards:

          12.7.1. Medical devices should be designed and manufactured to protect the user and the patient from mechanical hazards arising from durability, stability, moving parts and the like.

          12.7.2. Medical devices should be designed and manufactured in a way that minimizes the hazards arising from the vibrations of the medical device, unless their vibrations are part of the specified performance, especially taking into account the means and technical developments limiting the vibrations at the source.

          12.7.3. Medical devices should be designed and manufactured in a way that minimizes the hazards arising from the sound produced by the medical device, especially considering the means and technical developments that limit the sound produced at the source, if the sounds they make are not a part of the specified performance.

          12.7.4. Terminals that need to be used manually by the user and connections to electrical, gas, hydraulic and pneumatic energy sources should be designed and manufactured in a way that minimizes possible risks.

          12.7.5. Except for parts and areas intended to provide heat or to reach certain temperatures, the parts of medical devices that are touched and their environment must not reach a dangerous temperature under normal use.

          12.8. Protection against dangers that may occur for the patient in the delivery of substances or energy supply:

          12.8.1. Medical devices for delivering substances or supplying energy to the patient must be designed and manufactured in such a way that the appropriate flow rate can be maintained and maintained with sufficient precision to guarantee the safety of the user and the patient.

          12.8.2. Medical devices should be equipped with devices that prevent and / or show flow rate irregularities.

          Medical devices should be equipped with an appropriate system to prevent the energy from the energy and / or material source from accidentally reaching a dangerous level.

          12.9. Control and indicator functions should be clearly stated on the medical device. When the information required for the functioning of the medical device or the operating and adjustment parameters are specified with the help of an imaging system, this information should be understandable by the user and, when necessary, by the patient.

          13) Information given by the manufacturer:

          13.1. Each medical device should be accompanied by information that identifies the manufacturer and ensures a safe and appropriate use, taking into account the education and knowledge of potential users.

          This information should be given in detail in the user manual and on the label.

          The information required to ensure the safe use of the medical device should also be available on the medical device and / or on the packaging of each part or on the commercial packaging when necessary. If it is not possible to pack each item separately, this information should be included in the brochures of one or more medical devices.

          There should be an instruction manual on the package of each medical device. If safe use of Class I or IIa medical devices is possible without an instruction manual, the instruction manual may not be available.

          13.2. This information can be in the form of symbols when necessary. Symbol and identification colors must comply with harmonized standards. For those who do not have a standard, symbols and colors should be explained in the documents provided with the medical device.

          13.3. Information that should be included on the label:

          a) Manufacturer's name or commercial name and address; For imported medical devices, the name or trade name and address of the authorized representative and / or importer must also be included on the label or in the sales package or in the user manual,

          b) Detailed information that defines the contents of the packaging and the medical device and especially for the user,

          c) When necessary, the phrase "STERILE",

          ç) When necessary, batch code or serial number with the expression "LOT",

          d) If necessary, the expiry date in month and year,

          e) When required, the phrase "for single use",

          f) If the medical device is made on order, the phrase "It is a custom-made device",

          g) The phrase "For Clinical Research" in clinical research devices,

          ğ) Special storage and / or usage conditions,

          h) Special user manual,

          ı) Warnings and / or measures to be taken,

          i) For active medical devices, the date of manufacture to be specified in the batch / lot or serial number, apart from sub-paragraph (d),

          j) When required, the method of sterilization,

          k) With regard to container and medical devices containing radioactive substances, information on Turkey Atomic Energy Agency permit to be obtained from,

          l) If the medical device contains a human blood derivative, the statement indicates this.

          searched.

          13.4. If the intended use of the medical device is not easily understood by the user, the manufacturer should clearly indicate the intended use of the medical device on the label and in the user manual.

          13.5. When necessary and possible; All situations that may cause any potential danger arising from the medical device and its components within the same lot / lot must be clearly stated in the user manual.

          13.6. When necessary, the user manual should contain the following information:

          a) All the details specified in section (13.3) of this Annex, except for sub clauses (ç) and (d),

          b) Performance and undesirable side effects specified in section (3) of this Annex,

          c) If the medical device needs to be placed or connected with other medical devices or equipment in order to operate in accordance with its intended use, all the features and sufficient information required to ensure a safe integrity,

          ç) All information required to verify whether the installation of the medical device is appropriate and whether it will work correctly and safely, and all information about the quality and frequency of maintenance and calibration required to ensure that medical devices always work properly and safely,

          d) Information to avoid serious dangers that may occur due to the implantation of the medical device, when necessary,

          e) Information on the dangers of interaction caused by the medical device during specific treatment or research,

          f) Necessary information regarding the application of resterilization methods if the packaging ensuring the sterility is broken and when necessary,

          g) If the medical device is a reusable medical device; If it is required to be cleaned, disinfected and re-sterilized, information on the necessary methods including the sterilization method and how many times it can be reused,

          If the medical device needs to be sterilized before use, the medical device must still meet the "General Requirements" of this Annex when the instructions for cleaning and sterilization provided by the manufacturer are properly followed.

          In disposable medical devices, information regarding the risk to occur in case of re-use of the medical device, technical elements and features known by the manufacturer should be included in the user manual. This is Attachment13.1. In cases where the user manual is not required in accordance with the part numbered, the said information should be given to the user upon request.

          ğ) Before the medical device is ready for use, all the necessary process or details of operation (eg sterilization, final assembly),

          h) In medical devices emitting radiation for medical purposes; Detailed information about the distribution, intensity, type and nature of radiation,

          The instruction manual should also contain details for the healthcare professionals to inform patients about contraindications and measures to be taken. These details should include in particular:

          ı) Precautions to be taken when there is a change in the performance of the medical device,

          i) Measures to be taken in case of exposure to changes in predictable environmental conditions such as magnetic fields, external electrical effects, electrostatic discharge, pressure or pressure changes, acceleration, thermal ignition sources,

          j) All necessary information about the product, including the restrictions on the selection of the substance to be applied, on the medical devices intended to deliver the medicinal product or products,

          k) Measures to be taken against special or unexpected dangers that may occur during the destruction of the medical device,

          l) Medicinal substances or human blood derivatives to be administered as an integral part in accordance with part (7.4) of this Annex,

          m) The degree of accuracy prescribed for medical devices with measurement functions,

          n) The publication date or the latest update information of the user manual.

          EC II

          EC DECLARATION OF CONFORMITY

          (Full Quality Assurance System)

          1) The manufacturer ensures that the approved quality system specified in part (3) of this Annex is applied for the design, manufacture and final control of medical devices; also, with regard to surveillance and inspection, it is subject to the procedures specified in sections (3.3), (4) and (5) of this Annex.

          2) EC Declaration of Conformity is the process showing that the manufacturer who fulfills the requirements specified in part (1) of this Annex ensures and declares that the products in question comply with the provisions of this Regulation.

          Accordingly, the manufacturer attaches the CE mark in accordance with Article 17 of this Regulation and prepares a written declaration of conformity. This declaration, to be kept by the manufacturer, should include all manufactured medical devices and the devices in question should be clearly identified with the product name, product code or other phrases.

          3) Quality system:

          3.1. The manufacturer applies to the notified body for an evaluation of the quality system. This application includes the following:

          - Manufacturer's name and address, names and addresses of all other manufacturing sites in the quality system,

          - All information about the medical device or medical device group subject to processing,

          - A written statement that no application has been made to another notified body for the same medical devices,

          - Documentation on the quality system,

          - The manufacturer's commitment to fulfill the requirements of the approved quality system,

          - The manufacturer's commitment that the approved quality system will be maintained completely and effectively,

          - The manufacturer's commitment to review the data obtained from medical devices in the post-production phase, including the provisions in Annex X, to establish a system to implement the necessary corrective actions and to keep this system up to date. This commitment includes the obligation of the manufacturer to immediately notify the Ministry of the following situations:

          a) Has caused or caused serious deterioration in the health status of the patient or the user or death;

          1) Deterioration or deviation of the characteristics and / or performance of the medical device,

          2) The deficiencies in the user manual and label,

          b) Technical and medical reasons depending on the characteristics and performance of the medical device that cause the systematic withdrawal of the same type of medical devices from the market by the manufacturer of the same type of medical devices due to the reasons specified in paragraph (a).

          3.2. Quality System Implementation should ensure that medical devices comply with the provisions of this Regulation at all stages from design to final control. For the quality system, all the conditions, requirements and elements adopted by the manufacturer, quality records, work done, plans, programs should be included in a document in a written, sequential and systematic manner.

          This quality system certification should specifically include the documents, data and records obtained from the processes specified in clause (c) as well as the following.

          a) Quality targets of the manufacturer,

          b) The organizational structure of the business and especially;

          - Responsibilities, authorities and institutional structuring of the authorities and employees regarding the design quality and manufacture of the medical device,

          - Methods to control the effective functioning of the quality system to ensure that medical devices and designs are of the desired quality, including the control of non-conforming medical devices,

          - If the design, manufacture and / or final inspection and testing of the medical device or its parts are carried out by third parties, methods for monitoring the effective functioning of the quality system, and in particular the form and extent of control applied to that third party;

          c) Procedures for monitoring and verifying the design of medical devices, related documents and especially the following issues;

          - General description of the medical device and its intended use, including the envisaged changes,

          - When the standards specified in Article 7 of this Regulation are not fully implemented, risk analysis results including the definition of the solutions adopted to meet the basic requirements of medical devices and design features including the standards to be applied,

          - Systematic measurements, processes and design control and verification techniques to be used during the design of medical devices,

          - If the medical device is connected to other medical device (s) in order to operate in accordance with its purpose, proof that these medical device (s) with the characteristics specified by their manufacturers are in compliance with the basic requirements in cases where they are interconnected,

          - the statement referred to in Annex I / 7.4 indicating whether the medical device contains a human blood derivative or a substance as part of the whole, and the test results required to evaluate the usefulness, quality and safety of the human blood derivative or substance, taking into account the intended purpose of the medical device. data,

          - A statement regarding whether animal originated tissues are used in the manufacture of the medical device in accordance with the regulations on animal originated tissues,

          - solutions adopted in accordance with part (2) of Annex I,

          Pre-clinical evaluation,

          - clinical evaluation specified in Annex X,

          - Label and user manual draft if required

          ç) Inspection and quality assurance techniques at the manufacturing stage;

          - Processes, transactions and related documents to be used especially in sterilization and purchasing,

          - Medical device identification procedures that are prepared and kept up-to-date using drawings, specifications or other relevant documents at every stage of production,

          d) Appropriate tests and trials to be made before, during and after manufacturing, how often they will be done, the aspects that will enable the retrospective monitoring of the calibration of the test devices and test devices used.

          3.3. The notified body inspects the quality system to determine whether it complies with the requirements specified in part (3.2) of this Annex. Quality systems to which relevant harmonized standards are applied are deemed to comply with these requirements.

          At least one member of the assessment team should have assessment experience with the relevant technology. The evaluation process should include the evaluation of the documents related to the design of the medical device on a sample basis and an on-site inspection of the manufacturer and, where appropriate, the manufacturer's supplier and / or contractor for inspection of the manufacturing processes.

          The decision is notified to the manufacturer, together with the inspection results and annotated evaluation.

          3.4. The manufacturer informs the notified body that approves the quality system about all proposals for significant changes to the quality system or medical device type. The notified body evaluates the proposed changes and examines whether these changes in the quality system comply with the requirements specified in part (3.2) of this Annex and notifies the manufacturer of its decision. This decision includes the results of the audit and an annotated evaluation.

          4) Examination of medical device design:

          4.1. In addition to the requirements specified in part (3) of this Annex, the manufacturer submits the design file of the medical device planned to be manufactured in accordance with part (3.1) of this Annex to the notified body for examination.

          4.2. The application should describe the design, manufacture and performance of the medical device in question and include the documents required to evaluate the medical device's compliance with the requirements of this Regulation, as specified in sub-clause (c) of part (3.2) of this Annex.

          4.3. The notified body examines the application and if the medical device conforms to the provisions of this Regulation, it issues the EC Design-Examination Certificate to the applicant. The notified body may request additional evidence and tests during the application process in order to assess compliance with the requirements of this Regulation. Certificate; It includes the results of the examination, the validity requirements, the data required in the definition of the approved design and, when necessary, the purpose of the medical device.

          In the case of medical devices specified in the second paragraph of Annex I / 7.4, the notified body consults the Ministry or the European Medical Products Evaluation Agency (EMEA) before taking a decision on the situation mentioned in that section. The Ministry or the European Medical Products Evaluation Agency (EMEA) gives its opinion within 210 (two hundred) days from the date the valid documents are delivered to it. This scientific opinion is included in the certification of the medical device. The notified body takes into account the issues expressed in the scientific opinion while making its decision and transmits its final decision to the Ministry and / or the European Medicines Evaluation Agency (EMEA).

          In the case of medical devices specified in the third paragraph of Annex I / 7.4, the scientific opinion of the European Medicines Assessment Agency (EMEA) should be included in the medical device documentation. The European Medicines Assessment Agency (EMEA) gives its scientific opinion within 210 (two hundred and ten) days from the date valid documents are delivered to it. The notified body takes the opinion of the European Medicines Assessment Agency (EMEA) while making its decision. If the scientific opinion of the European Medicines Assessment Agency (EMEA) is not positive, the notified body may not issue the certificate. The notified body transmits its final decision to the European Medicines Assessment Agency (EMEA).

          In the case of medical devices manufactured using tissues of animal origin, the notified body carries out the procedures in the relevant regulations.

          4.4. In case of design changes, if compliance with the essential requirements of this Directive or the conditions for the use of the medical device are affected, an additional approval must be obtained from the notified body that issued the EC Design-Examination Certificate. The applicant informs the notified body of all changes regarding the approved design. It receives "additional approval" in addition to the EC Design-Examination Certificate.

          5) Surveillance and control:

          5.1. The purpose of surveillance and inspection is to ensure that the manufacturer fully meets the requirements of the approved quality system.

          5.2. The manufacturer authorizes the notified body to carry out all necessary inspections and provides it with all necessary information. This information:

          - Documentation on the quality system,

          - Data such as analysis results, calculations, tests, solutions included in part (2) of Annex I, pre-clinical and clinical evaluations, post-market clinical monitoring plan and results foreseen in the design related part of the quality system,

          - Data such as inspection reports, test data, calibration data and reports on the qualifications of the relevant personnel foreseen in the manufacturing-related part of the quality system.

          5.3. The notified body periodically inspects and evaluates in order to ensure that the manufacturer complies with the approved quality system, and issues an evaluation report to the manufacturer.

          5.4. The notified body may make unannounced visits to the manufacturer. If deemed necessary during these visits, it can make or have tests done to check that the quality system is functioning well. The manufacturer is given an inspection report and a test report, if any.

          6) Administrative provisions:

          6.1. The manufacturer or his authorized representative keeps the following documents for at least 5 (five) years from the date of manufacture of the last medical device manufactured and at least 15 (fifteen) years for implantable devices to submit to the Ministry:

          - Declaration of conformity,

          - Quality system documents specified in part (3.1) of this Annex and in particular documents, data and records included in the second paragraph of part (3.2),

          - Changes specified in section (3.4) of this Annex,

          - Documents specified in section (4.2) of this Annex,

          - Notified body decisions and reports specified in sections (3.3), (4.3), (4.4), (5.3) and (5.4) of this Annex.

          7) Application for Class IIa and IIb medical devices:

          7.1. Except for the part numbered (4), this Annex can be applied to Class IIa and IIb medical devices specified in Article 11 of this Regulation.

          7.2. For Class IIa medical devices, the notified body, as part of the assessment in section (3.3), shall provide the technical documentation in subparagraph (c) of part (3.2) for at least one sample of each device subcategory in compliance with the provisions of this Regulation. evaluates.

          7.3. For class IIb medical devices, the notified body shall provide the technical documentation in subparagraph (c) of part (3.2) for at least one sample from each generic device group in terms of compliance with the provisions of this Regulation, as part of the assessment in section (3.3). evaluates.

          7.4. In the selection of samples, the notified body takes into account technological innovations, similarities in design, technology, manufacturing and sterilization methods, purpose of use and the evaluation results (e.g. in terms of physical, chemical and biological properties) made in accordance with this Regulation. The notified body makes it ready to present the justification for the samples taken to the Ministry.

          7.5. The notified body examines other samples within the scope of the surveillance and inspection evaluation specified in section (5).

          8) Application for medical devices containing human blood derivative:

          When the manufacture of each batch / lot of medical devices containing human blood derivatives is completed, the manufacturer informs the notified body about the placing on the market of the medical device lot / lot, and regarding their placing on the market, the state laboratory or another laboratory designated by the Ministry shall comply with the provisions of the Regulations on Human Medicinal Products Licensing. sends the official certificate issued according to the notified body.

          EC III

          EC TYPE REVIEW

          1) EC Type examination; It is the process of certifying the conformity of the sample representing the production with the provisions of this Regulation by the notified body.

          2) The application includes the following:

          - manufacturer's name and address; if the application is made by an authorized representative, the name and address of the authorized representative,

          - Documents specified in part (3) of this Annex for the conformity assessment of the sample representing the production defined as "type" in the provisions of this Regulation, a "type" prepared to be given to the notified body and other samples to be given when the notified body requests,

          - A written statement that no application has been made to another notified body for the same type.

          3) Documents issued; It should provide an understanding of the design, manufacture, and medical device performances and include the following:

          - a general description of the type and its intended use, including any planned changes.

          - Design drawings, in particular a detailed diagram showing the stipulated manufacturing methods and components, subgroups and circuits related to sterilization,

          - Definitions and explanations required for the operation of the medical device, understanding the drawings and schemes,

          - A list of the standards specified in Article 7 of this Regulation, which are fully or partially implemented, and a description of the solutions adopted to meet the basic requirements of this Regulation when these standards are not applied,

          - Results of operations such as design calculations, risk analyzes, examinations, technical tests,

          - Statement of whether a substance or human blood derivative specified in Annex I / 7.4 is included in the structure of the medical device as a whole, and of the tests performed to evaluate the safety, quality and usefulness of this substance or human blood derivative, taking into account the intended use of the medical device. data,

          - A statement regarding whether animal originated tissues are used in the manufacture of the medical device in accordance with the regulations on animal originated tissues,

          - solutions adopted in accordance with part (2) of Annex I,

          Pre-clinical evaluation,

          - clinical evaluation specified in Annex X,

          - Label and draft user manual, if required.

          4) Notified body:

          4.1. It examines and evaluates the conformity of the submitted documents to the type and whether the type is manufactured in accordance with the documents, whether the applicable provisions of the standards specified in article 7 of this Regulation are complied with, and records the evaluation results.

          4.2. For medical devices where the standards specified in Article 7 of this Regulation are not applied, appropriate examinations and tests are carried out to verify whether the solutions recommended by the manufacturer meet the basic requirements of this Regulation. If the medical device needs to be connected to other medical device (s) in order to operate in accordance with its intended purpose, compliance with the essential requirements must also be demonstrated when connected to the medical device (s) with the characteristics specified by the manufacturer.

          4.3. If the manufacturer chooses the relevant standards that are still in force, he or she will carry out the necessary examinations and tests to evaluate whether these standards are actually applied.

          4.4. Together with the applicant, it determines the place where the necessary examinations and tests will be performed.

          5) The  notified body issues the EC Type-Examination Certificate to the manufacturer who fulfills the provisions of this Regulation. The certificate contains the name and address of the manufacturer, the results of the inspection, the validity requirements and the data required for the identification of the approved type. Relevant parts of the document are attached to the certificate and a copy is kept by the notified body.

          In the case of medical devices specified in the second paragraph of Annex I / 7.4, the notified body consults the Ministry or the European Medicines Evaluation Agency (EMEA) before taking a decision on the situation referred to in this section. The Ministry or the European Medical Products Evaluation Agency (EMEA) gives its scientific opinion within 210 (two hundred and ten) days from the date that valid documents are delivered to it. This opinion is included in the certification of the medical device. The notified body takes into account the issues expressed in the scientific opinion while making its decision and transmits its final decision to the Ministry and / or the European Medicines Evaluation Agency (EMEA).

          In the case of medical devices specified in the third paragraph of Annex I / 7.4, the scientific opinion of the European Medicines Assessment Agency (EMEA) should be included in the medical device documentation. The European Medicines Assessment Agency (EMEA) gives its scientific opinion within 210 (two hundred and ten) days from the date valid documents are delivered to it. The notified body takes the scientific opinion of the European Medicines Assessment Agency (EMEA) into consideration while making its decision. If the opinion of the European Medicines Assessment Agency (EMEA) is not positive, the notified body may not issue the certificate. The notified body transmits its final decision to the European Medicines Assessment Agency (EMEA).

          In the case of medical devices manufactured using tissues of animal origin, the notified body carries out the procedures in the relevant regulations.

          6) The applicant must notify the notified body that issues the EC Type-Examination Certificate of all significant changes made to the approved product.

          If the design changes affect compliance with the essential requirements of this Regulation or the requirements for the use of the product, additional approval must be obtained from the notified body that issued the EC Type-Examination Certificate for these changes. If required, the applicant receives additional approval in addition to the first EC Type-Examination Certificate.

          7) Administrative provisions:

          7.1. Other notified bodies may obtain a copy of the EC Type-Examination Certificates and / or their annexes. Attachments of the certificate are given to other notified bodies upon justified request, with the knowledge of the manufacturer.

          7.2. The manufacturer or its authorized representative keeps a copy of the EC Type-Examination Certificate and their supplementary supplementary documents together with the technical documents for at least 5 (five) years from the manufacture of the last medical device. The storage period for implantable devices is at least 15 (fifteen) years from the last medical device manufacturing.

          EK IV

          EC VERIFICATION

          1) EC verification; It is the process in which the manufacturer or his authorized representative declares and guarantees that the medical devices subject to the procedures described in part (4) of this Annex comply with the type defined in the EC Type-Examination Certificate and comply with the provisions of the relevant Regulation.

          2) The manufacturer takes the necessary measures regarding the manufacturing method in order for the manufactured medical devices to comply with the provisions of this Regulation and all the features of the type defined in the EC Type-Examination Certificate. Before starting production, the manufacturer prepares the documents showing the conformity of the manufacturing process, especially the required sterilization, all the routine operations, the provisions stipulated to ensure the homogeneity of the production, the type defined in the EC Type-Examination Certificate of the medical device and the relevant requirements of the Regulation. The manufacturer attaches the CE mark in accordance with Article 17 of the Regulation and prepares a declaration of conformity.

          In addition, the manufacturer applies the provisions of Sections (3) and (4) of Annex V solely for manufacturing processes intended to ensure and maintain sterility in medical devices placed on the market in sterile form.

          3) The manufacturer is responsible for establishing a system for reviewing the data obtained from medical devices at the post-production stage, including the provisions included in Annex X, and for implementing the necessary corrective actions, and keeping this system up to date. In this context, the manufacturer has the obligation to immediately notify the Ministry of the following situations:

          a) Has caused or caused serious deterioration in the health status of the patient or the user or death;

          1) Deterioration or deviation of the characteristics and / or performance of the medical device,

          2) The deficiencies in the user manual and label,

          b) Technical and medical reasons depending on the characteristics and performance of the medical device that cause the systematic withdrawal of the same type of medical devices from the market by the manufacturer of the same type of medical devices due to the reasons specified in paragraph (a).

          4) According to the decision of the manufacturer, the notified body tests and controls each medical device as specified in section (5) of this Annex or performs statistical verification of the products as specified in section (6), in order to verify whether the requirements stipulated by the Regulation are fulfilled or not, and performs reviews.

          The above-mentioned controls are not applied in the manufacturing process designed to ensure sterilization.

          5) Verification of each medical device with tests and controls:

          5.1. Each medical device is examined individually. Whenever possible, appropriate tests or equivalent tests defined in the relevant standards stipulated in Article 7 of this Regulation are carried out to verify the conformity of the medical device with the type defined in the EC Type-Examination Certificate and the relevant requirements of the Regulation.

          5.2. The notified body prints or prints its own identification number on each approved medical device and issues a written certificate of conformity for all tests performed.

          6) Statistical verification:

          6.1. The manufacturer must present the final products with homogeneous batch / lot numbers.

          6.2. Random samples are taken from each batch / lot. These samples are examined individually. Whenever possible, appropriate tests or equivalent tests defined in the relevant standards stipulated in Article 7 of this Regulation are carried out to verify the conformity of the medical device with the type defined in the EC Type-Examination Certificate and the relevant requirements of the Regulation in order to determine whether the batch / lot is accepted or rejected.

          6.3. Statistical control of the medical device is based on attributes and / or variables that require functionally specific sampling schemes that provide a high level of safety and performance in accordance with the latest technology. This sampling scheme is created in accordance with the relevant standards specified in Article 7 of the Regulation, taking into account the special nature of the device category in question.

          6.4. If the batch / lot is accepted, the notified body prints or prints its own identification number on each medical device and issues a written certificate of conformity regarding the tests performed. All medical devices in the accepted batch / lot, with the exception of unsuitable samples, may be placed on the market.

          If a batch / lot is rejected, the notified body takes the necessary measures to prevent that batch / lot from being placed on the market. In the event of frequent rejection of the batch / lot, the notified body may suspend statistical verification.

          The manufacturer may, under the responsibility of the notified body, print the identification number of the notified body during the manufacturing process.

          7) Administrative provisions:

          The manufacturer or his authorized representative keeps the following documents for at least 5 (five) years from the date of manufacture of the last medical device and at least 15 (fifteen) years for implantable devices, to submit to the Ministry:

          - Declaration of conformity,

          - Documents specified in Part (2) of this Annex,

          - Documents specified in sections (5.2) and (6.4) of this Annex,

          - If required, the EC Type-Examination Certificate specified in Annex III.

          8) Application for Class IIa medical devices:

          This Annex can be applied to Class IIa medical devices in article 11 of the Regulation, taking into account the following issues.

          8.1. The manufacturer guarantees and declares with a declaration of conformity that it manufactures Class IIa products in accordance with the technical documents specified in Part (3) of Annex VII, except for parts (1) and (2) of this Annex, and that they meet the relevant requirements of this Regulation.

          8.2. With the exception of sections (1), (2), (5) and (6) of this Annex, the verifications carried out by the notified body with the technical documents specified in Part (3) of Annex VII are intended to confirm the conformity of Class IIa products.

          9) Application for medical devices containing human blood derivative:

          In medical devices containing human blood derivatives, when the manufacture of each medical device lot / lot is completed and verified according to section (6), the manufacturer informs the notified body about the placing on the market of this medical device lot / lot and regarding their placing on the market. sends the official certificate issued by the state laboratory or another laboratory designated by the Ministry to the notified body in accordance with the provisions of the Regulations on Registration of Medicinal Products for Human Use.

          EK V

          EC DECLARATION OF CONFORMITY

          (Production Quality Assurance)

          1) By applying the approved quality system for manufacturing, the manufacturer performs the final controls of the medical devices in question as specified in part (3) of this Annex; it is also subject to the surveillance and control specified in section (4) of this Annex.

          2) EC declaration of conformity; It is the process that guarantees and declares the conformity of the products in question to the type specified in the EC Type-Examination Certificate and the relevant provisions of this Regulation by the manufacturer who fulfills the requirements specified in part (1) of this Annex.

          The manufacturer attaches the CE mark in accordance with Article 17 of this Regulation and prepares a written declaration of conformity. This declaration includes all medical devices clearly identified by product name, product code or other phrases and is maintained by the manufacturer.

          3) Quality system:

          3.1. The manufacturer applies to the notified body for an evaluation of the quality system. This application includes:

          - manufacturer's name and address,

          - All information about the medical device or medical device group subject to processing,

          - A written statement that no application has been made to another notified body for the same medical devices,

          - Quality system documents,

          - Commitment to fulfill all requirements of the approved quality system,

          - Commitment to maintain the approved quality system completely and effectively,

          - When necessary, a copy of the approved type-related technical document and EC Type-Examination Certificates,

          - The manufacturer's commitment to establish a system for reviewing data obtained from medical devices in the post-production phase, including the provisions in Annex X, and to implement the necessary corrective actions, and to keep this system up to date. This commitment includes the obligation of the manufacturer to immediately notify the Ministry of the following situations:

          a) Has caused or caused serious deterioration in the health status of the patient or the user or death;

          1) Deterioration or deviation of the characteristics and / or performance of the medical device

          2) The deficiencies in the user manual and label,

          b) Technical and medical reasons depending on the characteristics and performance of the medical device that cause the systematic withdrawal of the same type of medical devices from the market by the manufacturer of the same type of medical devices due to the reasons specified in paragraph (a).

          3.2. The application of the quality system must ensure that the products conform to the type specified in the EC Type-Examination Certificate.

          All provisions, requirements and predictions adopted by the manufacturer for the quality system must be documented systematically and regularly in written policies and procedures. This quality system documentation should allow for the interpretation of quality policy and procedures such as quality plans, schedules, manuals and records in the same way.

          This document specifically includes the following definitions:

          a) Quality targets of the manufacturer,

          b) The organizational structure of the business and especially;

          - Responsibilities, authorities and institutional structuring of authorities and employees regarding the manufacture of medical devices,

          - The methods used to monitor the effective functioning of the quality system and the production of products of particularly desired quality, including the control of non-conforming medical devices,

          - If the manufacture and / or final inspection and testing of the medical device or its parts is carried out by third parties, the methods for monitoring the effective functioning of the quality system, and in particular the form and scope of the control applied to the third party;

          c) Inspection and quality assurance techniques during the manufacturing phase and especially;

          - Procedures, methods and related documents to be applied for sterilization and purchasing,

          - Medical device identification procedures that are prepared and kept up-to-date using drawings, specifications or other relevant documents at every stage of production,

          ç) Appropriate tests and trials to be carried out before, during and after manufacturing, how often they will be made, the aspects that will enable the retrospective monitoring of the calibration of the test devices and test devices used.

          3.3. The notified body conducts an audit to determine whether the quality system complies with the requirements specified in part (3.2) of this Annex. Quality systems to which relevant harmonized standards are applied are deemed to comply with these requirements.

          At least one member of the assessment team should have assessment experience with the relevant technology. In the evaluation process, the manufacturer and, if necessary, the manufacturer's supplier are also inspected on-site to check the manufacturing method. The decision is notified to the manufacturer, together with the inspection results and annotated evaluation.

          3.4. The manufacturer informs the notified body that approves the quality system of all proposals regarding significant changes in the quality system.

          The notified body evaluates the proposed changes and examines whether these changes in the quality system comply with the requirements set out in section (3.2) of this Annex. After receiving the information in question, the decision including the audit results and the annotated evaluation is notified to the manufacturer.

          4) Surveillance and control:

          4.1. The purpose of surveillance and inspection is to ensure that the manufacturer fully meets the requirements of the approved quality system.

          4.2. The manufacturer allows the notified body to carry out all necessary inspections and provides the organization with all necessary information, including the following information;

          - Documentation on the quality system,

          - technical documentation,

          - Data such as inspection reports, test data, calibration data, reports on the qualifications of the relevant personnel foreseen in the manufacturing part of the quality system.

          4.3. The notified body periodically inspects and evaluates in order to ensure that the manufacturer complies with the approved quality system, and issues an evaluation report to the manufacturer.

          4.4. In addition, the notified body may make unannounced visits to the manufacturer. If it deems necessary during these visits, it can make or get a test to check that the quality system is working well. The manufacturer is given an inspection report and, if tested, a test report.

          5) Administrative provisions:

          5.1. The manufacturer or his authorized representative keeps the following documents for at least 5 (five) years from the date of manufacture of the last medical device and at least 15 (fifteen) years for implantable devices, to submit to the Ministry:

          - Declaration of conformity,

          - Quality system documents specified in section (3.1) of this Annex,

          - Changes specified in section (3.4) of this Annex,

          - A copy of the EC Type-examination certificate specified in part (3.1) of this Annex and technical documents pertaining to the approved type,

          - Decisions and reports of the notified body specified in sections (4.3) and (4.4) of this Annex,

          - If required, the EC Type-Examination Certificate specified in Annex III.

          6) Application for Class IIa medical devices:

          This Annex can be applied to Class IIa medical devices in article 11 of the Regulation, taking into account the following.

          6.1. The manufacturer guarantees with a declaration of conformity that it manufactures Class IIa products in accordance with the technical documents specified in Part (3) of Annex VII, except for parts (2), (3.1) and (3.2) of this Annex, and that they meet the relevant requirements of this Regulation. and explains.

          6.2. For class IIa medical devices, the notified body shall provide the technical documentation listed in Part (3) of Annex VII for at least one sample of each device subcategory to comply with the provisions of this Regulation, as part of the assessment in section (3.3). evaluates.

          6.3. In the selection of samples, the notified body takes into account technological innovations, similarities in design, technology, manufacturing and sterilization methods, purpose of use and the evaluation results (e.g. in terms of physical, chemical and biological properties) made in accordance with this Regulation. The notified body makes it ready to present the justification for the samples taken to the Ministry.

          6.4. The notified body examines other samples within the scope of the surveillance and inspection evaluation in section (4.3).

          7) Application for medical devices containing human blood derivative:

          When the manufacture of each batch / lot of medical devices containing human blood derivatives is completed, the manufacturer informs the notified body about the placing on the market of the medical device lot / lot, and regarding their placing on the market, the state laboratory or another laboratory designated by the Ministry shall comply with the provisions of the Regulations on Human Medicinal Products Licensing. sends the official certificate issued according to the notified body.

          EK VI

          EC DECLARATION OF CONFORMITY

          (Product Quality Assurance)

          1) By applying the approved quality system for production, the manufacturer performs the final inspection and testing procedures of the medical devices in question as specified in section (3) of this Annex; it is also subject to the surveillance and control specified in section (4) of this Annex.

          In addition, the manufacturer applies the provisions of Sections (3) and (4) of Annex V solely for manufacturing processes intended to ensure and maintain sterility in medical devices placed on the market in sterile form.

          2) EC declaration of conformity; It is the process that guarantees and declares the conformity of the products in question to the type specified in the EC Type-Examination Certificate and the relevant provisions of this Regulation by the manufacturer who fulfills the requirements specified in part (1) of this Annex.

          The manufacturer attaches the CE mark in accordance with Article 17 of this Regulation and prepares a written declaration of conformity. This declaration includes all medical devices clearly identified by product name, product code or other phrases and is maintained by the manufacturer. The CE mark is placed with the identification number of the notified body implementing the procedures specified in this Annex.

          3) Quality system:

          3.1. The manufacturer applies to the notified body for an evaluation of the quality system.

          The application includes the following points:

          - manufacturer's name and address,

          - All information about the medical device or medical device group subject to processing,

          - A written statement stating that no application has been made to another notified body for the same product,

          - documents on the quality system,

          - The manufacturer's commitment to fulfill the requirements of the approved quality system,

          - manufacturer's commitment to maintain the approved quality system fully and effectively,

          - If necessary, a copy of the approved type technical document and the EC Type-Examination Certificate,

          - The manufacturer's commitment to establish a system for reviewing data obtained from medical devices in the post-production phase, including the provisions in Annex X, and to implement the necessary corrective actions, and to keep this system up to date. This commitment includes the obligation of the manufacturer to immediately notify the Ministry of the following situations:

          a) Has caused or caused serious deterioration in the health status of the patient or the user or death;

          1) Deterioration or deviation of the characteristics and / or performance of the medical device

          2) The deficiencies in the user manual and label,

          b) Technical and medical reasons depending on the characteristics and performance of the medical device that cause the systematic withdrawal of the same type of medical devices from the market by the manufacturer of the same type of medical devices due to the reasons specified in paragraph (a).

          3.2. Within the framework of the quality system, the sample of each medical device or its lot / lot is examined and appropriate tests or equivalent tests defined in the relevant standards stipulated in Article 7 of this Regulation are performed in order to ensure the conformity of the medical device with the type defined in the EC Type-Examination Certificate and the relevant provisions of the Regulation. All provisions, requirements and predictions adopted by the manufacturer must be systematically and regularly documented in the form of written measures, procedures and instructions. This quality system documentation should allow the interpretation of quality plans, programs, manuals and records in the same way.

          This document specifically includes the following definitions:

          - Quality objectives, organizational structure, responsibilities and authorities of employees in the organization regarding the quality of medical devices,

          - The examinations and tests made after manufacturing and the matters that will enable the calibration of test equipment to be traced backwards,

          - Methods of monitoring the effective functioning of the quality system,

          - Quality records such as reports on inspection, testing and calibration and the qualification of the relevant personnel,

          - If the manufacture and / or final inspection and testing of the medical device or its parts is carried out by third parties, the methods for monitoring the effective functioning of the quality system, and in particular the form and scope of control applied to the third party.

          The above inspections do not apply to manufacturing processes designed to ensure sterility.

          3.3. The notified body inspects the quality system to determine whether it complies with the requirements specified in part (3.2) of this Annex. Quality systems to which relevant harmonized standards are applied are deemed to comply with these requirements.

          At least one member of the assessment team should have assessment experience with the relevant technology. In the evaluation process, the manufacturer and, if necessary, the manufacturer's supplier are also inspected on-site to check the manufacturing method. The decision is notified to the manufacturer, together with the inspection results and annotated evaluation.

          3.4. The manufacturer informs the notified body that approves the quality system of all his designs regarding significant changes in the quality system.

          The notified body evaluates the proposed changes and examines whether these changes in the quality system comply with the requirements set out in section (3.2) of this Annex. After receiving the information in question, the decision including the audit results and the annotated evaluation is notified to the manufacturer.

          4) Surveillance and control:

          4.1. The purpose of surveillance and inspection is to ensure that the manufacturer fully meets the requirements of the approved quality system.

          4.2. The manufacturer authorizes the notified body for inspection, testing and inspection of storage places and provides the organization with all the necessary information, including the following information;

          - Quality system documents,

          - technical documentation,

          - Records of quality, such as inspection reports, test and calibration data, and qualifications of personnel.

          4.3. The notified body periodically inspects and evaluates and submits an evaluation report to the manufacturer to ensure that the quality system is applied.

          4.4. The notified body may make unannounced visits to the manufacturer. If it deems necessary during these visits, it can make or get a test to check that the quality system works well and the product conforms to the relevant requirements of this Regulation. For this purpose, the notified body takes a sample of the final product, examines it and applies the appropriate tests or equivalent tests defined in the standards stipulated in article 7 of the Regulation. The notified body takes the necessary measures in cases where one or more product samples are not suitable.

          The notified body issues an inspection report to the manufacturer and, if tested, a test report.

          5) Administrative provisions:

          5.1. The manufacturer or his authorized representative keeps the following documents for at least 5 (five) years from the date of manufacture of the last medical device and at least 15 (fifteen) years for implantable devices, to submit to the Ministry:

          - Declaration of conformity,

          - A copy of the EC Type-Examination Certificate specified in part (3.1) of this Annex and the technical documents related to the approved type,

          - the changes specified in part (3.4) of this Annex,

          - Notified body decisions and reports specified in the second paragraph of section (3.4) of this Annex and also in sections (4.3) and (4.4) of this Annex,

          - Where required, the certificate of conformity specified in Annex III.

          6) Application for Class IIa medical devices:

          This Annex can be applied to Class IIa medical devices in article 11 of the Regulation, taking into account the following.

          6.1. The manufacturer guarantees with a declaration of conformity that it manufactures Class IIa products in accordance with the technical documents specified in Part (3) of Annex VII, except for parts (2), (3.1) and (3.2) of this Annex, and that they meet the relevant requirements of this Regulation. and explains.

          6.2. For class IIa medical devices, the notified body shall provide the technical documentation listed in Part (3) of Annex VII for at least one sample of each device subcategory to comply with the provisions of this Regulation, as part of the assessment in section (3.3). evaluates.

          6.3. In the selection of samples, the notified body takes into account technological innovations, similarities in design, technology, manufacturing and sterilization methods, purpose of use and the evaluation results (e.g. in terms of physical, chemical and biological properties) made in accordance with this Regulation. The notified body makes it ready to present the justification for the samples taken to the Ministry.

          6.4. The notified body examines other samples within the scope of the surveillance and inspection evaluation in section (4.3).

          EK VII

          EC DECLARATION OF CONFORMITY

          1) EC Declaration of Conformity; The manufacturer or his authorized representative, who fulfills the obligations specified in section (2) of this Annex and the obligations specified in section (5) of this Annex for medical devices with measuring function and medical devices placed on the market sterile, has fulfilled these obligations and that the said devices are in accordance with this Regulation. It is the process that declares and guarantees compliance with the relevant provisions.

          2) The manufacturer should prepare the technical document described in part (3) of this Annex. The manufacturer or his authorized representative keeps this technical document containing the declaration of conformity for at least 5 (five) years from the date of the last medical device manufactured for the inspection of the authorities. The storage period for implantable devices is at least 15 (fifteen) years from the last medical device manufacturing.

          3) This technical document should allow the assessment of the medical device's compliance with the requirements of the Regulation. This document includes the following:

          - A general description of the product, including any changes planned and intended use,

          - Design drawings, detailed diagram showing the envisaged manufacturing methods and components, subgroups and circuits,

          - Definitions and explanations required for the operation of the medical device, understanding the drawings and schemes,

          - Risk analysis results and a list of the standards specified in Article 7 of this Regulation, which are fully or partially applied, and the definition of the solutions adopted to meet the basic requirements of this Regulation when these standards are not applied,

          - Description and validation report of the methods used for medical devices supplied to the market as sterile,

          - The inspections performed and the results such as design calculations; If the medical device is to be connected to other medical device (s) in order to operate in accordance with its purpose, proof that these medical device (s) with the characteristics specified by their manufacturers are in compliance with the basic requirements in cases where they are interconnected,

          - solutions adopted in accordance with part (2) of Annex I,

          Pre-clinical evaluation,

          - clinical evaluation prepared according to Annex X,

          - Label and user manual.

          4) The manufacturer is responsible for reviewing the data obtained from medical devices at the post-production stage, including the provisions contained in Annex X, taking into account the structure and risks of the medical device, and establishing a system for the implementation of the necessary corrective actions and keeping this system up-to-date. In this context, the manufacturer has the obligation to immediately notify the Ministry of the following situations:

          a) Has caused or caused serious deterioration in the health status of the patient or the user or death;

          1) Deterioration or deviation of the characteristics and / or performance of the medical device

          2) The deficiencies in the user manual and label,

          b) Technical and medical reasons depending on the characteristics and performance of the medical device that cause the systematic withdrawal of the same type of medical devices from the market by the manufacturer of the same type of medical devices due to the reasons specified in paragraph (a).

          5) With regard to medical devices placed on the market as sterile and medical devices with measuring function in Class I, the manufacturer shall not only comply with the requirements specified in this Annex, but also in Annex II, Annex IV, Annex V or Annex. Must comply with one of the procedures specified in VI.

          Implementation of the above Annexes and notified body response;

          - Manufacturing issues related to securing and maintaining sterile conditions in medical devices placed on the market as sterile,

          - Manufacturing issues related to the conformity of products to metrological requirements in medical devices with measurement functions,

          is limited to. In addition, the second paragraph of part (6) of this Annex shall apply to them.

          6) Application for Class IIa medical devices:

          This Annex can be applied to Class IIa medical devices in article 11 of the Regulation, taking into account the following exception.

          The provisions of this Supplement; When applied in conjunction with the procedures specified in Annex IV, Annex V or Annex VI, the declaration of conformity specified in the relevant Annexes is made in a single declaration. With regard to the declaration based on this Annex, the manufacturer declares and guarantees that the product design meets the relevant provisions of this Regulation.

          EK VIII

          DECLARATION ON SPECIAL PURPOSE DEVICES

          1) The manufacturer or its authorized representative prepares a declaration containing the information specified in part (2) of this Annex for custom-made devices or devices for clinical research purposes.

          2) This statement includes the following information:

          2.1. For custom-made devices;

          - manufacturer's name and address,

          - Information identifying the medical device,

          - A statement stating that the medical device will be used by a particular patient, together with the name of the patient,

          - The name of the doctor or other authorized person who prescribed the prescription and, if necessary, the name of the relevant clinic,

          - specific characteristics of the medical device specified in the prescription,

          - A statement explaining the conformity of the medical device in question with the essential requirements set out in Annex I and, in cases where it does not fully meet these requirements, along with the reasons thereof.

          2.2. For clinical investigational devices specified in Annex X;

          - device identification information,

          - clinical trial plan,

          - Investigator brochure,

          - Confirmation that those subject to research are covered by insurance,

          - Informed volunteer consent form,

          - a statement whether a substance or human blood derivative specified in Annex I / 7.4 is included in the structure of the device as a whole,

          - Statement regarding whether animal originated tissues are used in the manufacture of the device in accordance with the regulations regarding animal originated tissues,

          - Opinions of the relevant ethics committee and detailed explanations about these opinions,

          - Name of the institution responsible for the trial and the medical practitioner or other authorized personnel,

          - the place where the research was conducted, the starting date and the planned duration,

          - A statement stating the compliance of the device with the basic requirements other than the subjects covered by the research and all the measures taken to protect the safety and health of the patient.

          3) The manufacturer also to submit to the Ministry when necessary:

          3.1. It keeps the document regarding the design, manufacture, expected performance, actual performance and manufacturing location (s) of bespoke medical devices, in a way to allow an assessment that they meet the requirements of this Regulation.

          The manufacturer takes all necessary measures to ensure that the manufacturing method produces a medical device in accordance with the document specified in the first paragraph of this section.

          3.2. Documentation for clinical investigational devices should include the following information:

          - General description of the device and its intended use,

          - Design drawings, in particular a detailed diagram showing the stipulated manufacturing methods and components, subgroups and circuits related to sterilization,

          - Definitions and explanations required for the operation of the device, understanding the drawings and schemes,

          - Risk analysis results and a list of the standards specified in Article 7 of this Regulation, which are fully or partially applied, and the definition of the solutions adopted to meet the basic requirements of this Regulation when these standards are not applied,

          - Where the device contains a human blood derivative or a substance as part of a whole mentioned in Annex I / 7.4, taking into account the stated purpose of the device, the test results required to determine the usefulness, quality and safety of the human blood derivative or substance, data belonging to

          - Measures regarding risk management applied to reduce the risk of infection in cases where animal origin tissues are used in accordance with the regulations regarding animal originated tissues in the manufacture of the device,

          - Results such as applied inspections and technical tests and design calculations.

          The manufacturer takes all necessary measures to ensure that the device is manufactured in accordance with the document specified in the first paragraph of this section.

          The manufacturer accepts and undertakes to evaluate the effectiveness of these measures or to inspect when necessary.

          4) The information and documents stipulated in this Annex are kept for at least 5 (five) years. The storage period for implantable devices is at least 15 (fifteen) years.

          5) For bespoke medical devices, the manufacturer is responsible for reviewing the data obtained from medical devices at the post-production stage, including the provisions in Annex X, and implementing the necessary corrective actions. In this context, the manufacturer has the obligation to immediately notify the Ministry of the following situations:

          a) Has caused or caused serious deterioration in the health status of the patient or the user or death;

          1) Deterioration or deviation of the characteristics and / or performance of the medical device,

          2) The deficiencies in the user manual and label,

          b) Technical and medical reasons depending on the characteristics and performance of the medical device that cause the systematic withdrawal of the same type of medical devices from the market by the manufacturer of the same type of medical devices due to the reasons specified in paragraph (a).

          EK IX

          CLASSIFICATION RULES

          DEFINITIONS:

          1) Definitions included in the classification rules:

          1.1. Medical devices on a duration basis:

          - Temporary:  Medical devices that are normally intended for continuous use in less than 60 minutes.

          - Short term: Medical devices that are normally intended for continuous use for less than 30 days.

          - Long term:  Medical devices that are normally intended for continuous use for more than 30 days.

          1.2. Invasive devices:  These are medical devices that partially or completely penetrate, enter or insert into the body through the body opening or body surface.

          - Body opening:  Any natural opening in the body, including the outer surface of the eye socket, or an artificial opening that has been permanently opened (eg stoma).

          - Surgical invasive device:  These types of devices are invasive medical devices that are inserted into the body by passing the body surface with the help of a surgical intervention or instrument.

          Medical devices that are defined in accordance with the purpose of this Regulation and used by placing them in a place other than the existing entrances of the body are also defined as surgical invasive devices.

          - Implant devices: These  are medical devices that are completely implanted in the human body by surgical intervention or replaced by the eye surface or epithelial surface and remain in place after the insertion process.

          Medical devices that are partially placed in the human body by surgical operation and are expected to remain in place for at least 30 (thirty) days after the procedure are also defined as implant devices.

          1.3. Reusable surgical instruments: These are  medical devices that are used for cutting, piercing, scraping, stripping, joining, pulling, fastening or similar surgical procedures without connection with any active medical device and can be reused after these procedures are completed.

          1.4. Active medical devices: These are medical devices  that work with any electrical energy or power source and the conversion of this energy, except for the energy created by gravity or the human body naturally. Devices that allow the transfer of energy, substances and other elements between the medical device and the patient without any significant change are not considered active medical devices. Software that are medical devices alone are considered active medical devices.

          1.5. Active therapeutic devices:  Medical devices that support, change, replace or restore biological structures or functions, either alone or in combination with other medical devices, to treat or alleviate a disease, injury or disability.

          1.6. Active diagnostic devices:  Active medical devices used alone or in conjunction with other medical devices that provide information to detect, diagnose, monitor or treat physiological conditions, health conditions, diseases or genetic disorders.

          1.7. Central circulatory system:  Within the framework of this Regulation, the central circulatory system includes the following vessels:

          Arteriaepulmonalis, the aorta is coming up, the bow of the aorta, the aorta, and come down bifurcatioaortaya kadar, arteriaecoronariae, arteriacarotiscommunis, arteriacarotisexterna, arteriacarotisinterna, arteriaecerebralis, truncusbrachicephalicus, venaecordis, venaepulmonalis, the vena cava or the superior vena cava, inferior to Him.

          1.8. Central nervous system:  For the purpose of this Regulation, the central nervous system includes the brain, cerebrospinal membranes and spinal cord.

          II. APPLICATION RULES:

          2) Application rules:

          2.1. The application of the classification rules is determined by the intended purpose of the medical devices.

          2.2. If the medical device is to be used together with another medical device, the classification rule is applied to each medical device separately. Accessories are classified separately from the medical devices they are used with.

          2.3. Software that affects the use of the medical device or operates the medical device falls within the same category.

          2.4. If the medical device will not be used only in a certain part of the body, it is classified on the basis of the most critical place of use.

          2.5. If more than one rule can be applied to the same medical device depending on the performance determined by the manufacturer, the medical device is evaluated within the strictest rule within the scope of the highest classification.

          2.6. With regard to the calculation of the time specified in the part numbered (1.1) of the first section, continuous use means "the actual use of the medical device in line with its intended use". However, cessation of use of the medical device in order to be immediately replaced by the same or similar medical device is considered within the scope of the continuous use of the medical device in question.

          III. CLASSIFICATION:

          1) Non-invasive devices:

          1.1. Rule 1:

          All non-invasive devices are in Class I unless they fall under one of the following rules.

          1.2. Rule 2:

          All non-invasive devices for the collection or storage of blood, body fluids or tissues, infusion, delivery or administration of fluids or gases into the body;

          If it can be connected to active medical devices of Class IIa or higher,

          - In Class IIa, if it is intended for the exchange or storage of blood or other body fluids or for the purpose of preserving organs, organ parts or body tissues. In all other cases it falls within Class I.

          1.3. Rule 3:

          All non-invasive devices that alter the chemical or biological composition of blood, other body fluids or other fluids intended to be infused into the body fall within Class IIb. However, treatment; If it involves filtration, centrifuge or exchange of gas or heat, then it falls within Class IIa.

          1.4. Rule 4:

          All non-invasive devices that come into contact with injured skin;

          - It is in Class I if it is used as a mechanical barrier for absorption or suppression of secretions.

          - Medical devices intended to be used mainly in wounds caused by the destruction of the dermis layer and that only provide healing as a secondary purpose are included in Class IIb.

          - Medical devices used in all other situations, including medical devices primarily intended to improve the microenvironment of the wound, fall within Class IIa.

          2) Invasive devices:

          2.1. Rule 5:

          Except for surgical invasive devices, all body opening-related invasive devices connected only to a Class I active medical device:

          - Those intended for temporary use are in Class I.

          - Medical devices intended for short-term use fall within Class IIa. However, those used in the oral cavity up to the pharynx, in the ear canal or nasal cavity up to the eardrum fall into Class I.

          - Medical devices intended for long-term use fall in Class IIb. However, those that are not suitable for absorption through the mucous membranes and used in the oral cavity up to the pharynx, in the ear canal or nasal cavity up to the eardrum fall into Class IIa.

          With the exception of surgical invasive devices, all body opening-related invasive devices intended for use in conjunction with an active medical device classed Class IIa or higher fall into Class IIa.

          2.2. Rule 6:

          All temporary-use surgical invasive devices fall within Class IIa. But:

          - Surgical invasive devices that control, diagnose, monitor or correct a disorder in the heart or central circulatory system by direct contact with these parts of the body are included in Class III.

          - Reusable surgical instruments are in Class I.

          - Surgical invasive devices that are used by direct contact with the central nervous system are in Class III.

          - Surgical invasive devices intended to provide energy in the form of ionizing radiation fall within Class IIb.

          - Surgical invasive devices with biological effect or absorption of all or the majority fall into Class IIb.

          - If surgical invasive devices used to deliver drugs to the body pose a potential danger in terms of the way of use, then they are in Class IIb.

          2.3. Rule 7:

          All surgical invasive devices for short-term use fall in Class IIa except for:

          - Medical devices that control, diagnose, monitor or correct a disorder in the heart or the central circulatory system by direct contact with these parts of the body are included in Class III.

          - Surgical invasive devices that are used by direct contact with the central nervous system are in Class III.

          - Medical devices that provide energy in the form of ionizing radiation fall within Class IIb.

          - Surgical invasive devices that have biological effect or absorb all or most of them fall into Class III.

          - Medical devices that undergo chemical changes in the body or used for drug delivery, except those implanted in the tooth, are in Class IIb.

          2.4. Rule 8:

          Except for the following conditions, all implanted devices and long-term surgical invasive devices fall into Class IIb.

          - Medical devices implanted in teeth fall within Class IIa.

          - Medical devices used in direct contact with the heart, central circulatory system or central nervous system shall fall within Class III.

          - Medical devices that have biological effect or absorbed all or the majority of them fall into Class III.

          - Medical devices that undergo chemical changes in the body or used for drug delivery, except those placed in the tooth, are in Class III.

          - Breast implants are in Class III.

          - Shoulder, knee and hip joint replacement devices fall within Class III.

          3) Additional rules applicable to active devices:

          3.1. Rule 9:

          All active therapeutic devices for energizing or energy conversion fall within Class IIa. However, considering its structure, density and place of energy application, if it poses a potential risk in giving and receiving energy from the human body or in providing energy conversion, it is in Class IIb.

          Medical devices that monitor or control the performance of active therapeutic devices in Class IIb or all active devices that directly affect the performance of these devices are also included in Class IIb.

          3.2. Rule 10:

          Diagnostic active devices fall within Class IIa;

          - Medical devices that provide energy to be absorbed by the human body, excluding medical devices used to illuminate the patient's body in a visible spectrum,

          - Medical devices used to visualize the in vivo distribution of radiopharmaceuticals,

          - Medical devices that allow direct diagnosis or monitoring of vital physiological functions.

          However, medical devices intended to monitor changes in the nature of the patient's condition that may create immediate danger, such as changes in central nervous system activities, respiratory and cardiac functions, fall within Class IIb.

          All active devices that emit ionizing radiation and intended for interventional radiological diagnosis and treatment, and for controlling and monitoring these active devices, or that directly affect their performance, fall within Class IIb.

          3.3. Rule 11:

          All active devices that deliver and / or receive medicines, bodily fluids or other substances fall into Class IIa. However, considering the mode of administration, the relevant part of the body and the nature of the substances administered, this procedure is in Class IIb if it poses a potential risk.

          3.4. Rule 12:

          All other active devices are in Class I.

          4) Special rules:

          4.1. Rule 13:

          When used separately, all medical devices that contain a substance that is considered as a medicinal product and supports the effect of the medical device on human, according to the Registration Regulation for Medicinal Products for Human Use, fall into Class III.

          All medical devices containing human blood derivatives are in Class III.

          4.2. Rule 14:

          All medical devices used to prevent the transmission of contraceptive or sexually transmitted diseases are in Class IIb. However, if it is an implant or a long-term invasive device, it falls within Class III.

          4.3. Rule 15:

          Medical devices used to disinfect, clean, rinse, and, where necessary, moisten contact lenses, fall within Class IIb.

          Medical devices that are particularly useful for disinfecting medical devices fall within Class IIa. Medical devices intended for disinfecting invasive devices fall within Class IIb.

          This rule does not apply to products that physically clean medical devices other than contact lenses.

          4.4. Rule 16:

          Medical devices used specifically for the purpose of recording X-ray diagnostic images fall within Class IIa.

          4.5. Rule 17:

          All medical devices manufactured using animal tissues or dead tissue fragments are in Class III, except for medical devices intended to come into contact with intact skin only.

          5) Rule 18:

          Unlike other rules, blood bags fall into Class IIb.

          EK X

          CLINICAL EVALUATION

          1) General provisions:

          1.1. As a general rule, confirmation that the medical device meets the requirements in terms of performance and characteristics set out in sections (1) and (3) of Annex I, under normal conditions of use, and acceptance of the benefit-risk ratio specified in section (6) of Annex I. Evaluation of feasibility and side effects should be based on clinical data. The evaluation of these data, hereinafter referred to as "clinical evaluation", should follow a methodologically acceptable and defined procedure, taking into account relevant harmonized standards when necessary, based on one of the following points.

          1.1.1. The procedure in question;

          - Equivalence of the medical device with data relating to it and the medical device evaluated, and

          - If the data in question fully complies with the relevant basic requirements, it may be based on a critical evaluation of the relevant scientific literature available regarding the safety, performance, design features and intended use of the medical device.

          1.1.2. The procedure in question may be based on the critical evaluation of the results obtained from all clinical trials conducted.

          1.1.3. The procedure in question may be based on the critical evaluation to be made by combining the clinical data specified in sections (1.1.1) and (1.1.2).

          1.1a If implantable devices and Class III medical devices cannot be fully justified based on available clinical data, clinical investigation is conducted for these devices.

          1.1b Clinical evaluation and results obtained are documented. The documents in question and / or the information that fully describes them are included in the technical file of the medical device.

          1.1c Clinical evaluation and related documentation should be constantly updated based on data obtained from post-market surveillance and inspection. Within the scope of the post-market surveillance and inspection plan of the medical device, in cases where post-market clinical follow-up is not deemed necessary, this is fully justified and documented.

          1.1d In cases where it is not appropriate to demonstrate compliance with essential requirements based on clinical data, an appropriate justification is made, taking into account the characteristics of the interaction between the medical device and the body, the intended clinical performance and the manufacturer's claims and based on the risk management outcomes. This must be fully justified if the medical device's compliance with the essential requirements is to be demonstrated on the basis of performance evaluation, benchmark testing and pre-clinical evaluation only.

          1.2. In accordance with Article 20 of this Regulation, all data must remain confidential.

          2) Clinical trials:

          2.1. Purpose of clinical research;

          - Evaluation of the conformity of the performance of the medical device under normal conditions of use according to Part (3) of Annex I,

          - To evaluate any undesirable side effects in normal use conditions and whether this effect constitutes an acceptable risk when compared to the intended performance of the medical device.

          2.2. Ethical Reviews;

          Clinical trials must be conducted in accordance with the Declaration of Helsinki, adopted at the 18th World Medical Assembly held in Helsinki, Finland in 1964, and finalized by the World Medical Assembly. All measures to protect human health must be implemented within the framework of the Declaration of Helsinki. This Declaration covers every stage of the clinical trial, from the moment the need is recognized and the study is justified, until the results are published.

          2.3. Methods;

          2.3.1. Clinical trials should be carried out according to a plan that reflects scientific and technical information that is up-to-date, and should be determined to confirm or deny the manufacturer's claims regarding the medical device. These investigations should contain a sufficient number of observations to ensure the scientific validity of the results.

          2.3.2. The methods used to carry out the studies should be suitable for the medical device being examined.

          2.3.3. Clinical trials should be conducted under conditions similar to the use of a medical device under normal conditions.

          2.3.4. All appropriate features of the medical device, including those related to performance and reliability, and their effects on the patient should be examined.

          2.3.5. All serious adverse events must be fully recorded and immediately reported to the country (s) in which the clinical trial was conducted and to the Ministry together with the name of that country (s).

          2.3.6. Researches should be conducted by the relevant medical practitioner or an authorized person in their field in an appropriate environment.

          The relevant medical practitioner or an authorized person must have technical and clinical data on the medical device.

          2.3.7. The written report must include a critical evaluation of all data collected during the clinical trial and must be signed by the responsible medical practitioner or other authorized person.

          EK XI

          MINIMUM CHARACTERISTICS FOR APPOINTMENT OF THE APPROVED ORGANIZATION

          1) The manager of the notified body and the personnel carrying out the evaluation and verification process, as well as the persons who design, manufacture, supply, use or install the medical devices they inspect, or authorized representatives of these persons. These persons must not be directly involved in the design, construction, marketing or maintenance of medical devices or represent parties involved in these activities. These issues do not prevent the technical information exchange between the manufacturer and the institution.

          2) The notified body and its relevant personnel should have sufficient knowledge in the field of medical devices, and should carry out the evaluation and verification processes in accordance with professional ethical rules. In particular, they should be free from all pressure and monetary guidance from individuals and groups that may benefit from the verification results that may affect the audit results.

          Notified bodies can have some of the conformity assessment activities they have been assigned to a contractor / subcontractor that meets the provisions of this Annex and the Regulation. The notified body keeps all documents evaluating the qualifications of the contractor / subcontractor and related to the work done, to submit to the Ministry when necessary.

          3) The notified body must be competent to perform the task assigned to it according to one of the Annexes II, III, IV, V and VI or to have it done under its own responsibility.

          The notified body must have the necessary personnel and technical facilities to carry out the technical and administrative procedures required by the assessment and verification activities. In addition, it should employ a sufficient number of specialist personnel with experience and knowledge to evaluate the medical operability and performance of the medical device it reports, taking into account the requirements of this Regulation, in particular the requirements set out in Annex I. Equipment required for verifications must be available.

          4) Relevant staff of the notified body:

          - Vocational education that covers all of the assessment and verification processes assigned,

          - Adequate knowledge about the auditing rules and audit experience,

          - Ability to organize certificates, records and reports showing the audits they have performed,

          must have.

          5) The notified body must guarantee its impartiality. Fees should not depend on the number or results of the inspections performed.

          6) The notified body must assume legal responsibility for any action taken pursuant to the powers delegated to it.

          7) According to the provisions of this Regulation, the personnel of the notified body must keep all kinds of information learned due to their duties as professional secrets, except when requested by the competent administrative and judicial authorities.

          EC XII

          CE CONFORMITY MARK

          The CE conformity mark consists of the letters "CE".

          Ministry of Health Medical Devices Regulation 1

          - If the sign is enlarged or reduced, the proportions shown in the drawing above should not change.

          - CE mark letters should be in the same style and vertical dimensions. The vertical dimension cannot be smaller than 5 (five) millimeters. This minimal size is not mandatory for small sized medical devices.

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