Regulation 2017/746 - In vitro diagnostic medical devices - Main contents
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official title
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2017/746 |
| Original proposal | COM(2012)541  |
| CELEX number i | 32017R0746 |
| Document | 05-04-2017; Date of signature |
|---|---|
| Publication in Official Journal | 05-05-2017; OJ L 117 p. 176-332 |
| Signature | 05-04-2017 |
| Effect | 01-01-1001; Application Partial application See Art 113.3(f) 25-05-2017; Entry into force Date pub. +20 See Art 113.1 26-11-2017; Application Partial application See Art 113.3(b) 26-05-2018; Application Partial application See Art 113.3(c) 26-05-2019; Application Partial application See Art 113.3(h) 25-11-2020; Application Partial application See Art 113.3(d) 26-05-2022; Application Partial application See Art 113.3(b) 26-05-2022; Application See Art 113.2 26-05-2023; Application Partial application See Art 113.3(e) 27-11-2023; Application Partial application See Art 113.3(a) 26-05-2024; Application Partial application See Art 113.3(i) And 32022R0112 26-05-2025; Application Partial application See Art 113.3(e) 26-05-2027; Application Partial application See Art 113.3(e) And 113.3(g) 26-05-2028; Application Partial application See Art 113.3(j) And 32022R0112 |
| Deadline | 25-05-2017; See Art 108.2 25-08-2021; See Art 108.2 25-02-2022; See Art 106 27-05-2027; Review See Art 111 |
| End of validity | 31-12-9999 |
5.5.2017 |
EN |
Official Journal of the European Union |
L 117/176 |
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017
on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
Directive 98/79/EC of the European Parliament and of the Council (3) constitutes the Union regulatory framework for in vitro diagnostic medical devices. However, a fundamental revision of that Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation. |
(2) |
This Regulation aims to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of in vitro diagnostic medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods. As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices by ensuring, among other things, that data generated in performance studies are reliable and robust and that the safety of subjects participating in performance studies is protected. |
(3) |
This Regulation does not seek to harmonise rules relating to the further making available on the market of in vitro diagnostic medical devices after they have already been put into service, such as in the context of second-hand sales. |
(4) |
Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices should be introduced, to improve health and safety. |
(5) |
To the extent possible, guidance developed for in vitro diagnostic medical devices at international level, in particular in the context of the Global Harmonization Task Force and its follow-up initiative, the International Medical Devices Regulators Forum, should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical... |
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