Extension of the Medical Devices Regulation (MDR) transition

The European Parliament has voted to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in the EU. The amendment was passed to address concerns around device supply, notified body capacity and manufacturer preparedness, and was adopted by a vote of 537 to three with 24 abstentions. The decision came after European Health Commissioner Stella Kyriakides proposed a postponement to prevent tens of thousands of medical devices from going off the market because they could not meet MDR requirements. The amendment will take effect immediately upon publication in the Official Journal.

In short, the statement outlines the conditional extension dates for certain classes of medical devices to comply with the European Union's Medical Device Regulation. Class III custom-made devices must comply by May 26, 2026, while Class III and IIb implantable devices have until December 31, 2027, with exceptions. Class IIa, IIb, and Class Is,m devices have until December 31, 2028. Additionally, the "sell-off" date for all legacy devices has been removed, including for IVDR legacy devices.

What this means will get clear shortly as more guidance is expected to come.

You can find the amendment for the MDR and IVDR here: https://bit.ly/3Kbwbua