Regulation 2017/746 on In Vitro Diagnostic Medical Devices
In line with the opinion of the European Union Commission and the European Economic and Social Committee of the European Parliament, after taking the opinion of the Committee of the Regions, it prepared the regulation on in vitro medical devices, acting according to legislation. This regulation is the regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017.
Grounds for the Preparation of the Regulation
In accordance with Article 114 and Article 168 (4)(c) of the Treaty on the Functioning of the European Union, with the proposal of the European Commission, it was arranged to establish the Union regulatory scope for in vitro medical devices. While supporting innovations in in vitro medical devices, it is necessary to determine the high level of safety, health and to make significant changes in this sustainable, transparent and predictable regulatory scope.
The regulation aims to ensure that in vitro medical devices operate smoothly in the domestic market, taking into account the best level of protection of the health of users and patients, and taking into account the small and medium-level enterprises working in this field. The regulation also aims to set standards for quality and high safety classes for in vitro medical devices. These objectives will be achieved simultaneously, inextricably linked, without being primary or secondary. Related to Article 114 of the EUA (Treaty on the Functioning of the European Union), this regulation aims to harmonize the rules regarding market supply and user service of in vitro medical devices. Thus, it ensures that these products benefit from the free circulation principle. In addition to its other purposes in line with article 168 (4)(c) of the ABIA, it aims to ensure that performance studies data are robust and reliable. It determines the quality and safety standards of in vitro medical devices by ensuring the safety and protection of volunteers participating in performance studies.
It is not intended to harmonize circulation and keeping on the market by exchanging hands, as in the context of second-hand sales, of in vitro medical devices that have been put into service. It also determines the scope and definitions of the regulation in line with the regulations presented by the reasons for its preparation. Pursuant to article 114 and article 168(4)(c) of the EUA, it aims to determine the standards of in vitro medical devices and users specified in the objectives. For this purpose, simultaneously within the scope and definitions, the harmonization of the circulation of the products in the market and the definitions of the scope related to these directions are included.
Definitions for the Purposes of the Regulation
For the purposes of the regulation, some definitions are applied. These definitions are the definition of in vitro medical devices by the manufacturer to be used during examinations of blood and tissue, samples to be obtained from the human body, to provide information on the types of treatments, in the process of administering diseases and treatments, and in monitoring for the definition of treatment measures. Sample containers are also considered to be in vitro devices.
Placing the Devices on the Market, Putting them on the Circulation and Obligations of the Operators
This regulation also regulates the legislative status of products. In this process, the Commission also ensures that the legislative status of the products in the member countries is examined when necessary.
The regulation aims to ensure the stages of placing on the market and putting into service and performance tests, devices in free circulation in accordance with the relevant law. It also provides enforcement and regulation on distance sales, the use of harmonized standards, common specifications, and the general obligations of manufacturers. The general obligations of the importers and the general obligations of the distributors are also specified in the regulation. The regulation also determines the obligations between the persons providing the supply and circulation of in vitro medical devices on the market in general terms.
Electronic records of economic enterprises are determined in the regulation, in other parts of which circulation together with the electronic system related to the registration of economic enterprises.
Notified Bodies under the Regulation
Within the scope of the regulation, the obligations and purposes of the applications made by the notified bodies and organizations, the conformity assessment bodies for branch/representation and contracting, assignment have been determined.
General Information on Conformity Assessment and Classification
The classification of the devices is also carried out in accordance with the classifications, taking into account the risks they contain in accordance with the purpose of use and structure. Conformity assessment procedures, including these assessment procedures in notified bodies and detailing the assessments are also specified in these bylaws. Conformity certificates are also considered in this context.
The final provisions of the regulation are also stated in the 20th section of the regulation. These provisions ensure the implementation of the committee procedure. s. It allows you to set aside time and schedule yourself to take advantage of delegation and delegation.
In the evaluation, the commission monitors and evaluates the usable month of May, which can be used as much as 27 2027 to be reviewed, to prepare for implementation and to mature.
This historic planning takes place on the twentieth day after the Regulation is published in the Official Journal of the European Union. This regulation will be implemented on 26 May 2022. Exceptionally, the aging date changes.