Regulation (EU) 2023/607 has entered into force, extending the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC.
Class III 12/2027, all others 12/2028 EUR-Lex - 52023PC0010 - EN - EUR-Lex (europa.eu) All certificates issued by notified bodies in accordance with those Directives from 25/05/2017 that were still valid on 26/05/2021 and have not been withdrawn since will remain valid until:
✅ 31/12/2027, 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; ✅ 31/12/2028, for Class IIb devices other than those covered by the previous point, for Class IIa devices, and for Class I devices placed on the market in sterile condition or with a measuring function.
✅ 26/05/2026, for Class III custom-made implantable devices
Devices lawfully placed on the market may continue to be made available on the market or put into service in accordance with: ✅ Directives 90/385/EEC and 93/42/EEC, before 26 May 2021 ✅ Directive 98/79/EC, before 26 May 2022.
Certificates issued by notified bodies in accordance with those Directives from 25/05/2017 that were still valid on 26/05/2021 but expired before 20/03/2023 will be considered valid under certain conditions.
This new extension provides a breathing space for manufacturers of #dispositivosmédicos put into service before 26/05/2021. In my opinion, it must be managed properly by notified bodies in order to prioritise the certification of new #medicaldevices, and to give some relief to recently created companies that, as of today, are waiting for a notified body to accept the application for their innovative devices.