Regulation 2017/746 - In vitro diagnostic medical devices

Please note

This page contains a limited version of this dossier in the EU Monitor.

1.

Current status

This regulation has been published on May  5, 2017 and entered into force on May 25, 2017.

2.

Key information

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 EN
CELEX number i 32017R0746

3.

Key dates

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) And 113.3(fa) And 113.3(fb)
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)
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)
31-12-2030; Application Partial application See Art 113.3(j)
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

4.

Legislative text

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...


More

This text has been adopted from EUR-Lex.

5.

Original proposal

 

6.

Sources and disclaimer

For further information you may want to consult the following sources that have been used to compile this dossier:

This dossier is compiled each night drawing from aforementioned sources through automated processes. We have invested a great deal in optimising the programming underlying these processes. However, we cannot guarantee the sources we draw our information from nor the resulting dossier are without fault.

 

7.

Full version

This page is also available in a full version containing the summary of legislation, the legal context, de Europese rechtsgrond, other dossiers related to the dossier at hand, the related cases of the European Court of Justice and finally consultations relevant to the dossier at hand.

The full version is available for registered users of the EU Monitor by ANP and PDC Informatie Architectuur.

8.

EU Monitor

The EU Monitor enables its users to keep track of the European process of lawmaking, focusing on the relevant dossiers. It automatically signals developments in your chosen topics of interest. Apologies to unregistered users, we can no longer add new users.This service will discontinue in the near future.