RegulatoryOfficial

Commission publishes new harmonised standards decisions under MDR and IVDR on 9 November

🇪🇺 European Commission (DG SANTE) · Tue 10 Nov 2026

Two Commission Implementing Decisions dated 9 November 2026 add to the lists of harmonised standards references for medical devices and in vitro diagnostics, according to DG SANTE.

The European Commission has announced new harmonised standards for medical devices. Its updated standardisation page lists two Implementing Decisions adopted on 9 November 2026. Decision (EU) 2026/2479 relates to Regulation (EU) 2017/745 (MDR), and Decision (EU) 2026/2481 relates to Regulation (EU) 2017/746 (IVDR).

The announcement, dated 10 November, does not say which individual standards the decisions cover. Manufacturers will need to read the decisions themselves to see the specific references.

As the Commission explains, CEN and CENELEC develop these standards in response to a Commission standardisation request issued under Regulation (EU) No 1025/2012. Once the references appear in the Official Journal of the European Union, voluntary use of the standards gives a presumption of conformity with the requirements of the Regulations they cover. The request, M/575, was issued on 14 April 2021 and amended on 31 January 2023 and 27 May 2024.

The new decisions follow earlier 2026 publications. For the MDR, the page lists decisions of 28 January, 1 April (with a corrigendum to the 11 June decision) and 11 June 2026. For the IVDR, it lists decisions of 28 January and 15 June 2026. The Commission's lists go back to July 2021 for both regulations. The page also points to guidance document MDCG 2021-5 rev.1 on standardisation for medical devices and an appendix on the transition to the 'EU REP' symbol in EN ISO 15223-1.

What it means for your team

  • Check the full text of Decisions (EU) 2026/2479 (MDR) and 2026/2481 (IVDR) to identify which standard references have been added or changed.
  • Compare the new references with the standards cited in your technical documentation and conformity assessment files, and plan updates where needed.
  • Use the Commission's consolidated lists and MDCG 2021-5 rev.1 for guidance on applying harmonised standards under the MDR and IVDR.

Official source: European Commission (DG SANTE) ↗

Article written by VigiEye from the official source (European Commission (DG SANTE)). AI-assisted; check the source before acting.

More Regulatory All →