Reg. (EU) 2023/607, amending Reg. (EU) 2017/745 and 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, has been published in the Official Journal of the EU.

In order to address the risk of shortages of medical devices in the EU due to the difficulty encountered by a large number of manufacturers (in particular, small and medium-sized enterprises) in demonstrating compliance with the requirements of the new Regulations, the European Parliament and the Council deemed it necessary to further extend 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.

In particular, under the specific conditions identified in Reg. (EU) 2023/607, certificates issued by notified bodies from 25 May 2017 that were still valid on 26 May 2021 and that have not been withdrawn afterwards and certificates issued by notified bodies from 25 May 2017 that were still valid on 26 May 2021 and that have expired before 20 March 2023 remain valid after the expiry of the deadline indicated on the certificate until 31 December 2027 (for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), or until 31 December 2028 (for all other class IIb devices, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function).

Furthermore, devices for which the conformity assessment procedure pursuant to Directive 93/42/EEC did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to Reg. (EU) 2017/745 requires the involvement of a notified body, may be placed on the market or put into service until 31 December 2028.

With reference to in vitro diagnostic medical devices, Reg. (EU) 2023/607 amends Reg. (EU) 2017/746 by providing that devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to Art. 110, para. 3, Reg. (EU) 2017/746 may continue to be made available on the market or put into service.

Reg. (EU) 2023/607 entered into force on 21 March 2023, the day of its publication in the EU Official Journal.