Market & Industry MedtecLIVE 2024

Amendments to the Medical Devices Regulation adopted

The European Parliament voted positively on the draft amendment to the Medical Device Regulation (MDR). Since the Council already gave its approval at the end of January, the amendment has now been de facto adopted. Manufacturers are thus given more time to transfer existing products to the MDR.

Depending on the risk class, the validity of MDD certificates is to be extended until 2027 or 2028. This deadline extension will provide important relief for manufacturers' and Notified Bodies' schedules.

Conditions for the extension

The extension is subject to certain conditions. That means more time will only be granted for products that are safe and for which manufacturers have already taken steps to transition to MDR: The application must be submitted no later than May 26, 2024, and the contractual agreement with the Notified Bodies must be concluded no later than September 26, 2024.

Also, the sales deadline for existing devices previously specified in the Medical Devices Regulation (MDR Art. 120(4)) and the In Vitro Diagnostics Regulation (IVDR) Art. 110(4) has been abolished to allow medical devices already on the market to be made available beyond the end date of May 2025.

Next step

The next official step for the amendment of the MDR/IVDR is the signature and subsequent publication in the Official Journal. On that date, the draft regulation will then enter into force.