read
According to Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, certificates issued by notified bodies under Directives 90/385/EEC and 93/42/EEC (AIMDD and MDD) after 25 May 2017 and still valid before 26 May 2021 shall remain valid after the end of the period indicated on the certificate until:
- 26 May 2026 for class III custom-made implantable devices;
- 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;
- 31 December 2028, for class IIb devices other than those mentioned above, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.
However, this only applies on the condition that the devices continue to comply with the AIMDD or MDD and there are no significant changes in the design and intended use. Furthermore, no later than 26 May 2024, the manufacturer (or the authorised representative) has lodged a formal application with a notified body in accordance with Annex VII MDR for conformity assessment, and the notified body and the manufacturer have signed a written agreement for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device before the date of expiry of the certificate.
Another requirement for the extension of the transition period is the establishment of a quality management system by the manufacturer no later than 26 May 2024, in accordance with MDR Article 10(9).
In addition, devices placed on the market in accordance with AIMDD and MDD prior to 26 May 2021 or in line with Directive 98/79/EG (IVDD) prior to 26 May 2022 may continue to be made available on the market or put into service. This provision removes the “sell-off” period for medical devices and in vitro diagnostic medical devices.
