Regulation 2020/561 - Amendment of Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions - Main contents
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Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2020/561 |
| Original proposal | COM(2020)144  |
| CELEX number i | 32020R0561 |
| Document | 23-04-2020; Date of signature |
|---|---|
| Publication in Official Journal | 24-04-2020; OJ L 130 p. 18-22 |
| Signature | 23-04-2020 |
| Effect | 24-04-2020; Entry into force Date pub. See Art 2 |
| End of validity | 31-12-9999 |
24.4.2020 |
EN |
Official Journal of the European Union |
L 130/18 |
REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 23 April 2020
amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
(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 point (c) of Article 168(4) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
After consulting the European Economic and Social Committee,
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (1),
Whereas:
(1) |
Regulation (EU) 2017/745 of the European Parliament and of the Council (2) establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards 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) 2017/745 sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such devices. Furthermore, Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directives 90/385/EEC (3) and 93/42/EEC (4), such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices, to improve health and safety. |
(2) |
The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to Member States and constitutes an immense burden for national authorities, health institutions, Union citizens, and economic operators. The public health crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745. Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745, such as the designation and work of notified bodies and the placing on the market and making available on the market of medical devices in the Union. |
(3) |
Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of Union citizens and to enable Member States to give necessary medical treatment to patients who are urgently in need of such treatment. |
(4) |
Given the unprecedented magnitude of the current challenges, and taking into account the complexity of Regulation (EU) 2017/745, it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as laid down therein. |
(5) |
In order 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, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745. Taking into account the COVID-19 outbreak and the associated public health crisis, its epidemiological development, as well as the... |
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