It was obvious that the industry and also EU country authorities grew increasingly alarmed with regards to the approaching 26 May 2024 deadline. It marks the day where manufacturers of legacy devices had to bring their products to full compliance to Regulation (EU) 2017/745 on medical devices (MDR). This was perceived as a huge problem due to the limited notified body capacity.
The Commission has now given in during the EPSCO Health Council meeting on December 9. It proposed extended staggered deadlines for medical devices depending on the device risk class.
As a result, instead of the current 2024 compliance deadline for all legacy products, the Commission suggested the following timelines and further items:
- 26 May 2027 for class III and class IIb products;
- 26 May 2028 for class IIa, and I needing the involvement of a notified body due to changed MDR classification rules;
- An extension of the validity of the certificates issued under the former Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) if needed for legal and practical reasons;
- The removal of the sell-off date of 26 May 2025. This last point was also proposed for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
Please note that this is a proposal, which is not yet legally valid. Final provisions and more background information are expected to be available in early 2023 and we will keep you updated. Also, we would like to reiterate that this will be applicable only for legacy devices.
Source: European Commission