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Harmonised standards

Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the basis of a Standardisation Request issued by the Commission according to Regulation (EU) No 1025/2012. Once their references are published by the Commission in the Official Journal of the European Union, the voluntary use of those standards confer presumption of conformity with the requirements of the Regulations they aim to cover.

The Commission issued a standardisation request to CEN and CENELEC on 14 April 2021. It is available in the “eNorm Platform - European Commission standardisation requests” as M/575 (EN version - FR and DE available, clicking on the linguistic icon). An amendment to the standardisation request was adopted on 31 January 2023: it is also available as M/575 Amd 1 in the EN, FR and DE versions.

The publications in the OJEU of references of harmonised standards under the medical devices regulations are available:

For Regulation (EU) 2017/745 on medical devices:

For Regulation (EU) 2017/746 on in vitro diagnostic medical devices:

Summary / consolidated lists of the above publications are available on the standardisation webpages on healthcare engineering: Medical devices, In vitro diagnostic medical devices.