Implementing regulation 2020/666 - Amendment of Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies - Main contents
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official title
Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies| Legal instrument | Implementing regulation |
|---|---|
| Number legal act | Implementing regulation 2020/666 |
| Regdoc number | C(2020)3351 |
| CELEX number i | 32020R0666 |
| Document | 18-05-2020; Date of adoption |
|---|---|
| Publication in Official Journal | 19-05-2020; OJ L 156 p. 2-5 |
| Effect | 19-05-2020; Entry into force Date pub. See Art 2 |
| End of validity | 31-12-9999 |
19.5.2020 |
EN |
Official Journal of the European Union |
L 156/2 |
COMMISSION IMPLEMENTING REGULATION (EU) 2020/666
of 18 May 2020
amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (1), and in particular Article 11(2) thereof,
Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2), and in particular Article 16(2) thereof,
Whereas:
(1) |
Commission Implementing Regulation (EU) No 920/2013 (3) sets out a common interpretation of the main elements of the criteria for designation of notified bodies laid down in Directives 90/385/EEC and 93/42/EEC. |
(2) |
The COVID-19 pandemic and the associated public health crisis presents an unprecedented challenge to Member States and other actors active in the field of medical devices. The public health crisis has created extraordinary circumstances that have a significant impact on various areas covered by the Union regulatory framework for medical devices, such as the designation and work of notified bodies, as well as the availability of vitally important medical devices in the Union. |
(3) |
In the context of the COVID-19 pandemic, Regulation (EU) 2020/561 of the European Parliament and of the Council (4) was adopted in order to defer by one year the application of those provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council (5) that would otherwise start to apply from 26 May 2020, including the provision repealing Directives 90/385/EEC and 93/42/EEC. |
(4) |
As a result, notified bodies designated under those Directives are able to certify medical devices for one additional year, until 25 May 2021. However, for a significant number of those notified bodies the designations will expire between 26 May 2020 and 25 May 2021. Without valid designation, those notified bodies would no longer be able to issue certificates, and ensure their continuous validity, which is a necessary requirement for the lawful placing on the market or putting into service of medical devices. |
(5) |
To avoid shortages of vitally important medical devices, it is therefore essential that notified bodies currently designated under Directives 90/385/EEC and 93/42/EEC are able to continue to operate until the new regulatory framework for medical devices under Regulation (EU) 2017/745 becomes applicable. |
(6) |
Implementing Regulation (EU) No 920/2013 sets out procedural rules and obligations for the renewal of the designation as notified body to be complied with by the designating authorities of Member States under Directives 90/385/EEC and 93/42/EEC. |
(7) |
The extraordinary circumstances created by the COVID-19 pandemic have a significant impact on the work of notified bodies, Member States and the Commission, regarding the renewal of the designation process. In particular, travel restrictions and public health measures, such as social distancing requirements, imposed by Member States, as well as the increased demand for resources to fight the COVID-19 pandemic and the associated public health crisis, prevent the relevant actors from carrying out the designation process in accordance with the procedural rules and obligations set out in Implementing Regulation (EU) No 920/2013. The deferral of the application of Regulation (EU) 2017/745 and the deferral of the repeal of Directives 90/385/EEC and 93/42/EEC make it necessary to renew designations of notified bodies that would otherwise expire before... |
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