93/42 / AT- 93/42 / EEC
Medical Device Description: Produced for the purpose of diagnosing, treating, monitoring and controlling, mitigating or relieving the victimization of a disease, injury or disability, researching, changing or replacing an anatomical or physiological function, contraception or for the purpose of administering medication alone or refers to all kinds of tools, instruments, devices, accessories or other materials that can be used together, including products that are used with computer software if necessary to fulfill its intended function, and also obtained from the tissues of inanimate animals.
Scope: It covers all activities of public institutions and organizations and real and legal persons related to the design, production, distribution, placing on the market, putting into service and use of medical devices and accessories. Medical devices containing human blood derivative as part of its function are also covered by this Regulation. If the medical device is used together with the medical product in order to fulfill its function, within the scope of the legislation regarding the medical product itself; The medical device is also considered within the scope of this Regulation.
The medical device is used as a single product in combination with a medical product or medicine, and if it is for single use, it is considered a medical product or drug and evaluated within the scope of the relevant legislation.
What is the purpose of the Medical Device Directive 93/42 / EC:
To define the conditions that medical devices must meet before they are placed on the market,Establishing conformity assessment procedures according to device classifications Reporting of existing mechanisms to national authorities to monitor and protect public health,
Out of scope products:
a) Invitro medical diagnostic devices,
b) Active medical devices that can be implanted in the human body,
c) Medicinal products,
d) Cosmetic products,
e) Except for human blood derivatives; human blood, blood products, human plasma or blood cells and human cells, tissues, transplant organs or products produced therefrom,
f) Tissues and cells of animal origin, except for devices containing inanimate animal tissues and products produced from non-living animal tissues,
g) Personal protection devices depending on the main intended use of the product.
The Medical Device Directive must meet the most basic requirements, including:
• Technical Documentation (Technical File) - The technical documentation must contain all information and validity / verification data of the medical device. This will demonstrate compliance with the essential requirements of the Medical Device Directive (Medical Devices-93/42 / EC).
• Risk Assessment - should include a risk assessment of your Product during use, material use, biocompatibility analyzes, infection and cross-infection risks and potential risks. The resulting documents become part of the Technical File.
• Quality System - Your organization must meet the quality system requirements of the Medical Device Directive (Medical Devices-93/42 / EC). EN ISO 13485 is a harmonized standard in the EU, a way to demonstrate compliance with the quality system requirements of the Medical Device Directive (Medical Devices-93/42 / EC) for its applicable annexes.
It is your responsibility to comply with the Medical Device Directive by affixing the CE mark to your device when all relevant requirements are met.
Classification
Devices, according to the potential risk situation arising from their design and production and the hazard levels they may create in terms of human health, I., IIa., IIb., And III. It is divided into four classes as class. The classification is made according to the principles specified in Annex-IX. The disputes that may arise between the manufacturer and the notified body regarding the application of the classification rules are resolved by the Ministry.
The following points are taken into consideration in conformity assessment processes:
a) Except for custom-made devices and clinical research devices; The manufacturer carries out the following procedures regarding conformity assessment:
1) In order to affix the CE mark on Class I devices, it only follows the process specified in Annex-VII and issues a declaration of conformity.
2) IIa. To affix the CE mark on class devices; i) Declaration of conformity process determined in Annex-II regarding the full quality assurance system, excluding article 4 of Annex-II or, rnii) With the process related to the declaration of conformity specified in Annex-VII It follows the type verification process or the declaration of conformity process specified in Annex-V regarding production quality assurance or the declaration of conformity process specified in Annex-VI regarding product quality assurance.
3) IIb. To affix the CE mark on class devices;
i) Declaration of conformity process specified in Annex-II regarding the full quality assurance system or, rnii) Type verification process specified in Annex-IV together with the type examination specified in Annex-III, or the type verification process specified in Annex-V regarding production quality assurance. follows the declaration of conformity process.
b) For custom-made devices, following the procedure specified in Annex-VIII, it regulates the declaration in this Annex. Submits a list of bespoke devices to the Ministry.
c) The manufacturer and / or the notified body takes into account the evaluation and verification results made in accordance with this Regulation during the process of declaration of conformity of the device at the intermediate stage of production.
d) The producer assigns its authorized representative in the country to initiate the procedures specified in ANNEX-III, ANNEX-IV, ANNEX-VII and ANNEX-VIII.
f) The notified body asks the applicant for the information and documents required to confirm compliance within the framework of the selected transaction.
g) Decisions taken by notified bodies in accordance with Annex-II and Annex-III are valid for a maximum of 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 is extended for the next five years.
h) Records and correspondence regarding the methods specified in subparagraph (a) of this article shall be written in at least two languages, Turkish and preferably English or French or German.
ı) When necessary, the Ministry may permit the placing on the market and putting into service within the country of individual devices, which have not been applied to the procedures specified in paragraph (a) of this article, but whose use will help in the protection of health.
Clinical Studies
Article in case of 13- producer or manufacturer to be outside Turkey, his authorized representative, clinical research devices for Annex VIII mentioned declaration and required on clinical trials will be informing the Ministry of verir.bakanlık, public health, and III in the public interest. Class devices and IIa. or IIb. It evaluates the research plan regarding the implants included in the classes and invasive devices used for a long time and informs the manufacturer of its decision within sixty days. However, if the relevant advisory committee gives a positive opinion on the research plan in question, it may give permission to the producer to initiate the clinical trial without waiting for the end of the sixty-day period.
In the case of devices other than those specified in the second paragraph of this article, if the relevant advisory commission gives a favorable opinion on the research plan, the producers may be allowed to immediately initiate clinical trials. - The report specified in Article 2.3.7 of X is ready to be submitted to the Ministry. The Ministry takes necessary and appropriate measures to protect public health and public interest in terms of clinical trials when necessary. If it is done for the stated purpose, only the relevant provisions of Annex X are applied for this.
Recording system
The Ministry keeps and monitors the devices that have been placed on the market and the records of the persons responsible for placing these devices on the market in a standard format according to the principles and data specified in the relevant article.
Warning System:
The warning system regarding the negativities detected after placing the device on the market is as follows:
a) Ministry, I., IIa., IIb. or III. It takes the necessary measures to evaluate the data connected to a class device and submitted to its information regarding the following events in accordance with the provisions of this Regulation. These:
1) The deterioration or deviation of the features and / or performance of the device, the deficiencies in the user manual and the label that may lead to serious deterioration or death in the health of the patient or the user,
2) Technical and medical reasons depending on the characteristics and performance of a device for the reasons that cause the device to be systematically withdrawn from the market by the manufacturer of the same type of devices and are specified in sub-paragraph (1) of this paragraph.
b) If outside the producer or manufacturer in Turkey his authorized representative, physicians or health care institutions and organizations of this Article (a) of paragraph (1) of article in obliged to inform the Ministry about the specified conditions. The Ministry, in the case of physicians or health care institutions and organizations from the device manufacturer or the manufacturer's statement regarding Turkey will take all necessary measures to be outside to be aware of the condition of his authorized representative.
c) if necessary, the Ministry, in case the manufacturer or of being outside Turkey with their authorized representative inspects the site issues and the evaluation results, without prejudice matters in this Regulation, Article 18, provides information to the Commission by the Undersecretariat channel.
