Reaction to economic challenges

by Daniel Wurm

Extension of the transitional arrangements for in-vitro diagnostics in the European Union

The European Commission recently announced an extension of the transitional arrangements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. This measure is in response to economic concerns, as many in-vitro diagnostics on the market do not yet comply with the new regulations. This applies in particular to products with a higher risk class.

According to the current legal situation, in-vitro diagnostics with a higher risk class should comply with the new regulations by 26 May 2025 and products in the lower risk classes by 26 May 2027. In view of the current situation, the European Commission has now decided to extend the transitional periods.

Accordingly, products in risk class D have a new transitional period until December 2027, while the deadline for risk class C has been extended to December 2028. Class A and B products should now comply with the new regulations by December 2029.

This extension gives manufacturers more time to adapt their products to the stricter requirements of the regulation. Higher-risk products in particular require careful review and adaptation to ensure compliance with the new regulations.

The European Commission is also aiming to accelerate the operational readiness of EUDAMED. Full functionality, which was originally planned for the second quarter of 2026, is now to be achieved by the end of 2025. As a result, the mandatory use of the platform will also be brought forward. This accelerated implementation of EUDAMED will help to improve efficiency and transparency in the regulation of in-vitro diagnostics. Companies should prepare for these changes in order to meet the new requirements and ensure a smooth transition.