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Commission cites revised EN ISO 11137-1:2026 radiation sterilisation standard for in vitro diagnostics under IVDR

🇪🇺 EUR-Lex · Tue 10 Nov 2026

Implementing Decision (EU) 2026/2481 updates the IVDR harmonised standards list for sterilisation of health care products and defers withdrawal of the earlier version of EN ISO 11137-1.

The European Commission has adopted Implementing Decision (EU) 2026/2481 of 9 November 2026, amending Implementing Decision (EU) 2021/1195 on harmonised standards for in vitro diagnostic medical devices. It was published in the Official Journal on 10 November 2026.

According to the recitals, CEN and Cenelec revised EN ISO 11137-1:2015, on sterilization of health care products, together with its amendment EN ISO 11137-1:2015/A2:2019. The revision produced a superseding standard, EN ISO 11137-1:2026. The Commission assessed it with the two standardisation bodies against its 2021 standardisation request and concluded that it satisfies the requirements of Regulation (EU) 2017/746 (IVDR) that it is meant to cover. Its reference is therefore to be published in the Official Journal.

The decision also provides for the reference to the earlier version, EN ISO 11137-1:2015 with its A2:2019 amendment, to be deleted from the Annex to Decision 2021/1195. The Commission says the withdrawal of that reference is deferred, to give manufacturers and other economic operators enough time to adapt their processes and devices. The excerpt supplied does not include the operative articles, so the exact withdrawal date is not available here.

The decision enters into force on the day of its publication. As general context, under Article 8(1) of the IVDR, devices that conform to harmonised standards whose references are published in the Official Journal are presumed to conform to the requirements those standards cover.

What it means for your team

  • Manufacturers of sterilised IVDs that rely on EN ISO 11137-1 should check the full text of the decision for the date on which the 2015 version stops giving a presumption of conformity.
  • Quality teams should plan a gap assessment against EN ISO 11137-1:2026, as the new reference is already published and can be used to support presumption of conformity.
  • Technical documentation and declarations of conformity that cite the 2015 standard and its A2:2019 amendment will need updating once the transition ends.

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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