EU - New Publication of Harmonised Standards Under the Medical Devices Regulations – April 2025
Business description
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.
Countries:
01 European Union
Product categories:
Medical Devices
Technical aspects:
Safety
Business fields:
P.05 Medical
Regions:
Europe
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