Approved Institution Certification Activities (Our Solution Partners with Approved Institutions)
- ISO 13485 Certification
- CE Certification Audits (Annex II, V)
• Pre-Audit and Gap Analysis
Safety tests of Electrical Medical Devices according to EN 60601 standard
• Certification of Class I Devices
SOME INFORMATION ABOUT THE REGULATION
Medical Device:
Produced for the purpose of diagnosing, treating, monitoring and controlling, alleviating or relieving the victimization of a disease, injury, disability on a person, researching, changing or replacing an anatomical or physiological function, contraception or just for administering medication, alone or refers to all kinds of tools, tools, 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 disposable, it is considered a medical product or drug and evaluated within the scope of the relevant legislation.
Out of scope products:
a) Invitro medical diagnostic devices,
b) Active medical devices implantable in the human body,
c) Medicinal products,
d) Cosmetic products,
e) Except for human blood derivatives; human blood, blood products, human source plasma or
blood cells and human cells, tissues, transplant organs or products produced therefrom,
f) Except for devices containing inanimate animal tissues and products produced from non-living animal tissues
tissues and cells of animal origin,
g) Personal protection devices depending on the main intended use of the product.
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 a class. Classification is made according to the principles specified in Annex-IX.
Any disputes that may arise between the manufacturer and the notified body regarding the application of the classification rules are resolved by the Ministry.
Conformity Assessment Procedures
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, ii) Declaration of conformity determined in Annex-IV together 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) Excluding the declaration of conformity process specified in Annex-II regarding the full quality assurance system, excluding article 4 in Annex II, or
ii) Along with the type examination specified in Annex-III, the type verification process specified in Annex-IV, 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, it follows.
4) III. To affix the CE mark on class devices;
i) Declaration of conformity process specified in Annex-II regarding the full quality assurance system, or
ii) It follows the type verification process specified in ANNEX-IV together with the type examination specified in Annex-III or the declaration of conformity process specified in Annex-V regarding production quality assurance.
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.
e) The notified body asks the applicant for the information and documents required to confirm compliance within the framework of the selected transaction.
f) 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.
g) 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.
h) When necessary, the Ministry may permit the placing on the market and putting into service within the country of individual devices that have not been applied to the procedures specified in paragraph (a) of this article, but whose use will help protect health, upon a justified request.
Article 13 In case the producer or producer's Clinical Trials Turkey is outside its authorized representative, the statement referred to in Annex VIII for clinical research unit and gives information on clinical trials should be made to the Ministry. The Ministry, in terms of public health and public interest III. 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 permit the manufacturer to initiate the clinical trial without waiting for the end of the sixty-day period. In the case of devices other than the devices specified in the second paragraph of this article, if the relevant advisory commission gives a favorable opinion on the research plan, manufacturers may be allowed to start a clinical trial immediately. Clinical trials are conducted in accordance with the provisions specified in ANNEX-X and the manufacturer keeps the report specified in the article 2.3.7 of ANNEX-X ready to be submitted to the Ministry. When necessary, the Ministry takes necessary and appropriate measures to protect public health and public interest in terms of clinical trials. If the clinical trial is conducted for the purpose specified in the relevant conformity assessment declaration of the device using devices bearing the CE mark, only the relevant provisions of Annex-X are applied for this.
Registration System The Ministry keeps and monitors the records of the devices that have been put on the market and the persons responsible for placing these devices on the market, in accordance with the principles and data specified in the relevant article in a standard format. 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 cause or have caused 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 his 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.
Technical file:
The purpose of the technical file is to demonstrate the compliance of the directives with the requirements. The content of the technical file includes:
General product description including planned variations
• Design drawings and calculations, design drawings, descriptions, parts diagrams, accessories, etc.
• Techniques used to check and approve the design (Annex II)
• If harmonized standards are not used, definitions of solutions used to adapt the necessary mandatory requirements.
Proof that the device meets the mandatory requirements when used with other devices
• Definition of sterilization method, validation of sterilization
• Definition of quality assurance and audit techniques
• Risk analysis
Clinical Data
• Test Results and test equipment used (design validation)
Labels and usage instructions
Design File:
• If Annex II is selected in the conformity report activity, only design files are required for Class III devices.
• The implementation of the testing of Design Files should be by invitation of the notified body. Application design should describe production and performance.
• In addition, the application should include the documents specified in the article 3.2c of Annex II.
• After a successful design file has been tested, the Design File Certificate will be issued by the Notified Body.
• A certificate according to Annex II.3 associated with the MDD design file certificate (Annex II.4, MDD) is required to hit the CE mark on the Class III product.
• Design File changes must be approved by the approved institution.
ANNEX-I BASIC REQUIREMENTS
1. General Requirements
• Safety conditions of the patient, operator and 3rd parties
• Reasonable level of danger to the benefits provided
• Providing the intended performance…
2. Requirements in terms of Design and Production
Chemical, physical and biological properties
Infection and microbiological contamination
Construction and environmental features
Measuring function devices
Protection against radiation
Requirements for devices equipped or connected with an energy source
• Information provided by the manufacturer
ANNEX - II DECLARATION OF CONFORMITY (FULL QUALITY ASSURANCE SYSTEM)
ANNEX - III TYPE EXAMINATION
ANNEX - IV TYPE VERIFICATION
ANNEX - V TYPE DECLARATION OF CONFORMITY (PRODUCTION QUALITY ASSURANCE)
ANNEX - VI PRODUCT QUALITY ASSURANCE CONFORMITY STATEMENT
ANNEX - VII DECLARATION OF CONFORMITY
ANNEX - VIII DECLARATION ON SPECIAL PURPOSE DEVICES
ANNEX - IX CLASSIFICATION RULES
I. Definitions: Temporary, short-term, long-term, invasive devices, implant devices, body opening etc.
II. Rules of Practice
III. Classification: It is determined by 18 rules specified under this title.
ANNEX - X CLINICAL EVALUATIONS
As a general rule, the approval of the compliance of the requirements regarding the performance and features specified in the 1st and 3rd paragraphs of ANNEX-I, especially implant devices and III. For devices in the classroom, normal use of the device and assessment of side effects should be based on clinical data. Where appropriate, the adequacy of clinical data is based on the points contained in this annex, taking into account the relevant harmonized standards.
ANNEX - XI CHARACTERISTICS RELATED TO SELECTION OF THE NOTIFIED BODY
ANNEX - XII CE CONFORMITY MARK