20.03.2023 - 13:05   /   2,371

REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices is published in Official Journal of the European Union on 20.03.2023.

It is necessary to extend the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC and extend the transitional period during which devices that are in conformity with those Directives can lawfully be placed on the market.

The extension aims to ensure a high level of public health protection, including patient safety and avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements.

You can visit on the link below an official website of the EU for more information.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0607&from=EN