It is now official — the extension to the MDR transitional provisions has been published in the Official Journal of the EU (OJEU) and takes effect immediately.
What exactly has been extended?
The extension is only related to legacy devices, i.e., those with valid MDD/AIMDD CE Marking granted under MDR Article 120. This allows those products to remain on the market for a longer period.
The new MDR compliance dates for those products are:
- 31 December 2027- Class IIb implantable and Class III devices
- 31 December 2028 – Class IIb (all other), Class IIa, Class I sterile/measuring and MDD Class I self-certified devices upclassed under the MDR
The MDR extension (“delay”) is not:
- Applicable for any devices new to market. i.e., if you have a non-CE Marked product, and wish to obtain CE Marking, you must do so under the provisions of the MDR.
- An escape from eventual MDR CE Marking, i.e., in order to be eligible for the extended transition period, manufacturers must show movement toward MDR CE Marking.
The amendment to the Regulation also includes elimination of the sell-off dates (also for the IVDR) and further time for Class III custom-made device manufacturers to comply with the MDR.
For a more extensive overview of the caveats and conditions, please read: EU Commission Releases Official Proposal to Extend the MDR Transition Period
The EU Commission is expected to release guidance on how to uniformly implement the extension.
For example, you may be wondering how your CE Certificate will be handled. Will your Notified Body automatically issue a formal statement that the device is eligible for the maximum period? Or, is the market simply expected to understand that the CE certificate is valid, even if it is past the expiration date?
We are sure Notified Bodies will be hit with extensive requests and questions from their manufacturers. Ideally your Notified Body will have already formulated next steps (insomuch is possible with the information available today) and proactively communicate recommended actions with you.
Impact to the UK