Harmonized Standards Under Medical Device and IVD Regulations Trickle Through

Two new sets of standards have been officially recognized under the MDR and one under the IVDR. But progress is slow, and the numbers of standards updated remains exceptionally low nearly seven years after the regulations were adopted.

snail showing slow growth — EU Harmonized Standards Are being Published - But At A Snail's Pace

Two European Commission Implementing Decisions updating EU medical device harmonized standards have been published this month. One relates to the implementation of the Medical Device Regulation (MDR) and the other to the implementation of the IVD Regulation.

Implementing and Decision EU 2024/815 amends Implementing Decision (EU) 2021/1182 as regards harmonized standards in the context of the...