Let’s start with the basics. The risk class of your device and your chosen route of conformity affects your next steps.
Class 1 devices without a measuring function, that are not sterile, or aren’t reusable as classified under both MDD (Medical Device Directive) and MDR should have been in conformity to the provisions of the regulation by the date of application (May 26, 2021). Medical devices, except those mentioned before, that have been certified under the MDD and that require notified body involvement under the MDR, can continue to be put on the market or into service until the date of expiration of their certificate or until May 2025, whichever comes first, as long as they continue to conform to the directive, have not had any significant changes to their design or intended use, and their declaration of conformity have been issued before May 26, 2021.
These devices shall be certified under the EU MDR on or before the date of expiration of the certificate but no later than May 2024. They should also have a quality management system governing them in compliance with the provisions of the regulation related to market surveillance, post-market surveillance, vigilance, registration of devices, and registration of economic operators on or before the date of application of the regulation (May 2021). Products certified under Annex 4 under the MDD are no longer valid (expired on May 27, 2022) and should have been recertified under the new regulation.
All certificates issued under the MDD will now be void on the date of expiration of the certificate but no later than May 27, 2024. However, remember that all products requiring notified involvement under the MDR can continue to be put on the market or into service until May 26th, 2025. On May 27th of 2025, all devices with voided certificates will need to be withdrawn until proper CE marking under the EU MDR is achieved.
With those dates 2 to 3 years away, you may think you have plenty of time to certify your devices. However, that isn’t quite the case. Think about all the new requirements that the conformity assessment process under the EU MDR has. This includes but is not limited to the following:
Multiply several of the tasks by the number of devices, group of devices, or device categories your organization has and you realize this will not take a few months, it will take years to complete.
EU MDR (2017/745) Article 120: CL2017R0745EN0010010.0001_cp 1..1 (europa.eu)
MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements
MDCG 2020-2 rev.1 Class I transitional provisions under Article 120 (3 and 4) – (MDR)
MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
MDCG 2019-10 rev.1 Application of transitional provisions concerning the validity of certificates issued in accordance with the directives
MDCG 2022-14 Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs
MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD