The European Commission published, on Friday 6 January, a proposal for a regulation amending the medical devices legislation to avoid shortages of devices during the transition period to the new legislation (the medical devices Regulation EU/2017/745 applicable from 26 May 2021 and the in vitro diagnostic medical devices Regulation EU/2017/746).
The proposal was announced by the Commissioner for Health and Food Safety Stella Kyriakides at the Health Ministers’ meeting on 9 December (see EUROPE 13081/30) and the implementation of the new legislation is a priority for the Swedish Presidency of the EU Council (see EUROPE 13092/2).
The Commission clarifies that the amendments concerning the transitional period do not change the performance and safety requirements of the devices.
In particular, the Commission proposes extended transition periods for medical devices.
Two types of transition periods apply depending on the different levels of risk associated with the devices. Medical devices covered by a certificate or declaration of conformity issued before 26 May 2021 with a higher level of risk would be granted a more restricted deadline than medium or low risk medical devices, i.e. until 31 December 2027 instead of 26 May 2024 for higher risk machines and 31 December 2028 for medium or lower risk devices.
These extensions are subject to conditions to ensure the safety and effectiveness of the devices.
The European Commission also proposes to introduce a transitional period until 26 May 2026 for Class III custom-made implantable devices. However, manufacturers would have to request a conformity assessment of such devices before 26 May 2024 to benefit from this extension.
In addition, the European Commission proposes to extend the validity of licences issued until 26 May 2021 and to remove the “end of sale” date currently set in the two new regulations.
Link to the proposal: https://aeur.eu/f/4tf (Original version in French by Émilie Vanderhulst)