Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions

Summary:

Regulation (EU) 2020/561 - formally adopted by the European Union on 23 April 2020 - which amends Regulation (EU) 2017/745 on medical devices when it comes to its dates of application of certain provisions.

Further information:

Regulation (EU) 2017/745 establishes a new regulatory framework aimed at ensuring the smooth functioning of the internal market as regards medical devices covered by that Regulation.

The extraordinary circumstances surrounding the COVID-19 outbreak were expected to significantly impact various areas covered by this Regulation, which was likely to affect its proper implementation and application by the relevant stakeholders by the established date (26 May 2020).

This draft law proposes that the application of certain provisions of the Regulation is deferred by one year. At the same time, it is proposed that the date of repeal of Directives 90/385/EEC and 93/42/EEC are also deferred. This is to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty and to avoid potential market disruption. The proposed amendment also seeks to ensure that the Commission is able to adopt, in exceptional cases, EU-wide derogations in response to national derogations at the earliest date possible in order to address potential shortages EU-wide of vitally important medical devices in an effective manner.

The proposal was put forward by the European Commission on 3 April 2020. The European Parliament adopted its position on 17 April, which was endorsed by the Council of the European Union on 22 April. The Act was signed on the following day and published in the Official Journal on 24 April 2020.

• Primary Source

Official

EUR-LEX: COM(2020)144: Proposal for a Regulation amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2020:144:FIN

European Parliament: Legislative Observatory: Procedure File for Proposal on medical devices https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2020/0060(OLP)

European Commission: Press Release, 03/04/2020: Commission postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus https://ec.europa.eu/commission/presscorner/detail/en/ip_20_589

European Parliament: Press Release, 17/04/2020: Parliament decides to postpone new requirements for medical devices https://www.europarl.europa.eu/news/en/press-room/20200415IPR77113/

European Commission: Press Release, 23/04/2020: Medical Devices Regulation: Commission welcomes Council support to prioritise the fight against coronavirus https://ec.europa.eu/commission/presscorner/detail/en/ip_20_718

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