As expected, the Council of the European Union adopted the Commission’s proposal for a regulation amending the MDR and IVDR on 7 March 2023. Longer transition periods for the adaptation of medical devices and IVDs to the requirements of MDR and IVDR are therefore becoming a reality!
Different transition periods will apply to medical devices of different risk classes.
Requirements for an extension of time limits and “hidden” time limits
However, not all products will benefit equally from the longer transition periods. The proposed regulation links the possibility of not having to make products MDR-compliant until after the respective transition periods have expired to further strict conditions. Health Commissioner Stella Kyriakides emphasised: “It is important to note that this additional time can only be used for medical devices that are safe and for which manufacturers have already taken steps to transition to the Medical Device Regulation. Patient safety will always come first.”
Regardless of the status of a Notified Body certificate available for the products, claiming an extension always requires that the products in question:
- continue to be compliant with the requirements of the Directives (MDD, AIMD, IVDD);
- have not been significantly changed and no change has been made to their intended purpose;
- do not pose a safety risk or have the potential to pose a hazard.
In addition, the manufacturer must implement a quality management system that meets the requirements of the MDR and IVDR no later than 26 May 2024. For devices belonging to a higher risk class than Class I, close cooperation of the manufacturer with a Notified Body must also already exist or be initiated in a timely manner, aiming at a joint conformity assessment according to the requirements of the MDR. 26 May 2024 and 26 September 2024 are the deadlines for application procedures and contracting with Notified Bodies.
Recommendation for action by manufacturers
In order to benefit from the deadline extension, manufacturers must verify that their product falls within the scope of the Regulation and that the conditions for a deadline extension are met. For more information and a checklist showing possible ways to extend the deadline, see our one pager entitled “MDR deadline extension checklist”.back