Harmonised standards under the Regulations on medical devices and in vitro diagnostic medical devices 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).
A first amendment to the standardisation request was adopted on 31 January 2023, available as M/575 Amd 1 in the EN, FR and DE versions. A second amendment to the standardisation request was adopted on 27 May 2024, available as M/575 Amd 2 in the EN, FR and DE versions.
A consolidated version of the standardisation request M/575, for information purposes only, is available here.
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:
- Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 and Corrigendum
- Commission Implementing Decision (EU) 2026/760 of 1 April 2026
- Commission Implementing Decision (EU) 2026/193 of 28 January 2026
- Commission Implementing Decision (EU) 2025/2078 of 17 October 2025
- Commission Implementing Decision (EU) 2025/681 of 8 April 2025
- Commission Implementing Decision (EU) 2024/2631 of 8 October 2024
- Commission Implementing Decision (EU) 2024/815 of 6 March 2024
- Commission Implementing Decision (EU) 2023/1410 of 4 July 2023
- Commission Implementing Decision (EU) 2022/757 of 11 May 2022
- Commission Implementing Decision (EU) 2022/6 of 4 January 2022
- Commission Implementing Decision (EU) 2021/1182 of 16 July 2021
For Regulation (EU) 2017/746 on in vitro diagnostic medical devices:
- Commission Implementing Decision (EU) 2026/1313 of 15 June 2026
- Commission Implementing Decision (EU) 2026/197 of 28 January 2026
- Commission Implementing Decision (EU) 2025/679 of 8 April 2025
- Commission Implementing Decision (EU) 2024/2625 of 8 October 2024
- Commission Implementing Decision (EU) 2024/817 of 6 March 2024
- Commission Implementing Decision (EU) 2023/1411 of 4 July 2023
- Commission Implementing Decision (EU) 2022/729 of 11 May 2022
- Commission Implementing Decision (EU) 2022/15 of 6 January 2022
- Commission Implementing Decision (EU) 2021/1195 of 19 July 2021
Summary / consolidated lists of the above publications are available on the standardisation webpages on healthcare engineering: Medical devices, In vitro diagnostic medical devices.
Excerpt from the official page. The original is authoritative. Continue reading at EC Public Health ↗