The European Commission has issued a proposal to extend the transitional periods for manufacturers to comply with the prerequisites of the EU Medical Device Regulation (MDR) for some products.

The proposal:

  • amends article 120(2) and (3), subject to additional conditions, to extend the validity of European conformity certificates granted under the old directives until:
    • 31 December 2027 for class III products and class IIb implantable devices (with exceptions); or
    • 31 December 2028 for other class IIb products and class IIa, class Is, class Im devices; and
  • waives the sell-off dates (ie, 27 May 2025 in the MDR and 25 May 2025 to 26 May 2028 in the EU In Vitro Diagnostic Regulation), providing for the possibility of marketing medical devices placed on the market before the end of the transition period without a time restriction.

Currently, there are no indications that the proposal will not be adopted. Manufacturers should begin to assess whether they may benefit from the changes and which products could profit. If products are not eligible for the extensions, respective measures should be undertaken to remain or become compliant.

For further information on this topic please contact Eline van Nimwegen or Magdalena Kotyrba-Hagenmaier at Eversheds Sutherland LLP by telephone (+49 89 54565 0) or email ([email protected] or [email protected]). The Eversheds Sutherland LLP website can be accessed at www.eversheds-sutherland.com.