Regulation 2022/112 - Amendment of Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices - Main contents
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official title
Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2022/112 |
| Original proposal | COM(2021)627  |
| CELEX number i | 32022R0112 |
| Document | 25-01-2022; Date of signature |
|---|---|
| Publication in Official Journal | 28-01-2022; OJ L 19 p. 3-6 |
| Signature | 25-01-2022 |
| Effect | 28-01-2022; Entry into force Date pub. See Art 2 |
| End of validity | 31-12-9999 |
28.1.2022 |
EN |
Official Journal of the European Union |
L 19/3 |
REGULATION (EU) 2022/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 25 January 2022
amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices
(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), point (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) |
Regulation (EU) 2017/746 of the European Parliament and of the Council (3) establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices covered by that Regulation, 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, Regulation (EU) 2017/746 sets high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns as regards such devices. Furthermore, Regulation (EU) 2017/746 significantly reinforces key elements of the existing regulatory approach in Directive 98/79/EC of the European Parliament and of the Council (4), such as the supervision of notified bodies, risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices. |
(2) |
The COVID-19 pandemic and the associated public health crisis presented and continues to present an unprecedented challenge to Member States and constitutes an immense burden for national authorities, health institutions, Union citizens, notified bodies and economic operators. The public health crisis has created extraordinary circumstances that demand substantial additional resources, as well as the increased availability of vitally important in vitro diagnostic medical devices, which could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/746. Those extraordinary circumstances have a significant impact on various areas covered by that Regulation, such as the designation and work of notified bodies and the placing on the market and making available on the market of in vitro diagnostic medical devices in the Union. |
(3) |
In vitro diagnostic medical devices are essential to the health and safety of Union citizens, and SARS-CoV-2 tests, in particular, are vital in the fight against the pandemic. Therefore, it is necessary to ensure that there is an uninterrupted market supply of such devices in the Union. |
(4) |
Given the unprecedented magnitude of the current challenges, the additional resources needed by Member States, health institutions, notified bodies, economic operators and other relevant parties in order to fight the COVID-19 pandemic and the currently limited capacity of notified bodies, and taking into account the complexity of Regulation (EU) 2017/746, it is very likely that Member States, health institutions, notified bodies, economic operators and other relevant parties will not be in a position to ensure the proper implementation and full application of that Regulation from 26 May 2022 as laid down therein. |
(5) |
Moreover, the current transitional period provided... |
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