Regulation 2023/607 - Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices - Main contents
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official title
Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2023/607 |
| Original proposal | COM(2023)10  |
| CELEX number i | 32023R0607 |
| Document | 15-03-2023; Date of signature |
|---|---|
| Publication in Official Journal | 20-03-2023; OJ L 80 p. 24-29 |
| Signature | 15-03-2023 |
| Effect | 20-03-2023; Entry into force Date pub. See Art 3 |
| End of validity | 31-12-9999 |
20.3.2023 |
EN |
Official Journal of the European Union |
L 80/24 |
REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 15 March 2023
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical 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) |
Regulations (EU) 2017/745 (3) and (EU) 2017/746 (4) of the European Parliament and of the Council establish a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices and in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users. At the same time, Regulations (EU) 2017/745 and (EU) 2017/746 set high standards of quality and safety for medical devices and in vitro diagnostic medical devices in order to meet common safety concerns as regards such devices. Furthermore, both Regulations significantly reinforce key elements of the previous regulatory framework set out in Council Directives 90/385/EEC (5) and 93/42/EEC (6) and Directive 98/79/EC of the European Parliament and of the Council (7), such as the supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidence requirements, vigilance and market surveillance, and introduce provisions ensuring transparency and traceability in respect of medical devices and in vitro diagnostic medical devices. |
(2) |
Due to the impact of the COVID-19 pandemic, the date of application of Regulation (EU) 2017/745 was postponed by one year to 26 May 2021 by Regulation (EU) 2020/561 of the European Parliament and of the Council (8), while 26 May 2024 was maintained as the end date of the transitional period by which certain devices that continue to comply with Directive 90/385/EEC or Directive 93/42/EEC can lawfully be placed on the market or put into service. |
(3) |
Also due to the impact of the COVID-19 pandemic, the transitional period provided for in Regulation (EU) 2017/746 was already extended by Regulation (EU) 2022/112 of the European Parliament and of the Council (9). |
(4) |
Despite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC before 26 May 2024. It appears that a large number of manufacturers, especially small and medium-sized enterprises, are not sufficiently prepared to demonstrate compliance with the requirements of Regulation (EU) 2017/745, in particular when the complexity of those new requirements is taken into account. Therefore, it is very likely that many devices that can lawfully be placed on the market in accordance with the transitional provisions provided for in Regulation (EU) 2017/745 will not be certified in accordance with that Regulation before the end of the transitional period, which leads to the risk of shortages of medical devices in the Union. |
(5) |
In light of reports from healthcare professionals about the imminent risk of shortages of devices, it is necessary, as a matter of urgency, to extend the validity of... |
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