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Commission amends harmonised standard reference for sterilisation of healthcare products under EU device rules

🇪🇺 EUR-Lex · Tue 10 Nov 2026

Implementing Decision (EU) 2026/2481 changes the 2021 decision listing standards that give manufacturers a presumption of conformity, with sterilisation of healthcare products affected.

The European Commission adopted Implementing Decision (EU) 2026/2481 on 9 November 2026, amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for sterilisation of health care products. The act was published on EUR-Lex on 10 November 2026.

Implementing Decision (EU) 2021/1195 is the Commission's list of harmonised standards for the EU medical device framework. Harmonised standards that are cited in this way allow manufacturers to presume conformity with the relevant legal requirements when they apply them.

The material available does not identify which sterilisation standard is concerned, nor does it say what the amendment changes. It also does not give any transition arrangements or application dates. Readers will need to consult the full text of the decision on EUR-Lex for those details.

Manufacturers and quality assurance teams that rely on sterilisation standards to demonstrate device conformity may need to compare the amended reference with the standards cited in their current technical documentation.

What it means for your team

  • Obtain the full text of Decision (EU) 2026/2481 to identify the exact standard and the nature of the amendment, which are not specified in the summary.
  • Check the amended reference against the sterilisation standards cited in technical documentation and conformity assessment files.
  • Confirm any dates or transition provisions in the decision before adjusting validation or documentation plans.
  • Alert notified bodies and sterilisation suppliers if the change affects standards used in your existing device files.

Official source: EUR-Lex ↗

Article written by VigiEye from the official source (EUR-Lex). AI-assisted; check the source before acting.

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