Proposal for a Regulation amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices

Author (Corporate)
Series Details COM (2021) 627
Publication Date 14/01/2021
Content Type

Summary:

Legislative initiative tabled by the European Commission on 14 October 2021, introducing amendments to Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices. This is a text with EEA relevance.

Further information:

Regulation (EU) 2017/746 - also known as the In Vitro Diagnostic Medical Devices Regulation - updated rules on placing on the EU market, making available and putting into service in vitro diagnostic (IVD) medical devices for human use and their accessories. It also contains rules on the conduct of performance studies carried out in the European Union concerning IVD medical devices (or accessories).

This draft law proposes a progressive roll-out of the Regulation to prevent disruption in the supply of these healthcare products. The challenges posed by the COVID-19 (coronavirus) pandemic diverted resources from Member States, health institutions and economic operators towards addressing the crisis, thereby hampering the capacity to comply on time with the changes introduced. It does not change requirements in substance but only changes the transitional provisions to allow the Regulation's progressive rollout.

The proposal was tabled by the European Commission on 14 October 2021.

Source Link https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2021:627:FIN
Related Links
Official
European Commission: Public Health: Medical Devices https://ec.europa.eu/health/md_sector/overview_en
European Commission: Press Release, 14/10/2021: Public health: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209
European Commission: Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation (14 October 2021) https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210

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