EU - New Publication of Harmonised Standards Under the Medical Devices Regulations – April 2025

​Harmonised standards under the EU regulations for medical devices (Regulation (EU) 2017/745) and in vitro diagnostic devices (Regulation (EU) 2017/746) are developed by CEN and CENELEC. 

These organisations act on the basis of standardisation requests issued by the European Commission under Regulation (EU) No 1025/2012.

The voluntary use of these harmonised standards provides a presumption of conformity with the requirements of the Medical Device and In Vitro Diagnostic Device Regulations.