Last updated: 11 November 2026
TO view updates, click on the ‘+’ sign below.
Harmonised standards – Medical Devices
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.
For Regulation (EU) 2017/745 on medical devices:
- Commission Implementing Decision (EU) 2026/2479 of 9 November 2026
Commission Implementing Decision (EU) 2026/2479 of 9 November 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products, clinical investigation of medical devices for human subjects, natural rubber latex male condoms, biological evaluation of medical devices, washer-disinfectors, medical electrical equipment and small-bore connectors for liquids and gases in healthcare applications
For Regulation (EU) 2017/746 on in vitro diagnostic medical devices:
- Commission Implementing Decision (EU) 2026/2481 of 9 November 2026
Commission Implementing Decision (EU) 2026/2481 of 9 November 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for sterilization of health care products
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.1.23 (released to production on 9 November 2026) is now available on the PLM portal and eSubmission PLM Portal eAF.
Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
Rev 24 of the Q & A with the above title was published on 3 November 2026.
The following changes have been made to the document:
- Addition of Q&A 23 on the applicability of the approach to set AI for nitrosamines to other N-Nitroso compounds and
- Addition of Q&A 24 on the applicability of the LTL framework established in the ICH M7 guideline to nitrosamine impurities.
- Consequential updates to Q&As 10, 20 and 22.
- Addition of a new root cause to Q&A 4 and the approach for setting limits for nitrosamines originating in excipients in Q&A 10.
Source: EMA