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Commission updates harmonised standards list for medical devices, including sterilization and clinical investigation

🇪🇺 EUR-Lex · Tue 10 Nov 2026

Implementing Decision (EU) 2026/2479 amends Decision 2021/1182, reflecting revised standards on sterilization, clinical investigation, condoms, biological evaluation, washer-disinfectors, electrical equipment and small-bore connectors.

The European Commission adopted Implementing Decision (EU) 2026/2479 on 9 November 2026. It was published in the Official Journal on 10 November 2026 and amends Implementing Decision (EU) 2021/1182 on harmonised standards for medical devices.

The decision covers seven subject areas: 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.

The recitals explain that, under Article 8(1) of the Medical Device Regulation (EU) 2017/745, devices that conform to harmonised standards whose references are published in the Official Journal are presumed to conform with the requirements those standards cover. The revisions follow a Commission request to CEN and CENELEC, set out in Implementing Decision C(2021) 2406, to revise existing harmonised standards on medical devices to reflect technical and scientific progress.

Two of the revisions are described in the available text. EN ISO 11137-1:2015, together with its amendment A2:2019, and EN ISO 14155:2020, together with its amendment A11:2024, are superseded by EN ISO 11137-1:2026 and EN ISO 14155:2026. Other standards named as revised include EN ISO 4074:2015 on condoms, EN ISO 10993-6:2016 and EN ISO 10993-7:2008 (with its amendment and corrigendum) on biological evaluation, and EN ISO 15883-6:2015 on washer-disinfectors. The source text available to us cuts off partway through the recitals, so the full list of affected standards and any dates for the operative provisions are not covered here.

What it means for your team

  • Manufacturers should check their technical documentation against the full operative text and annexes of Decision 2026/2479 in the Official Journal, as the references and dates are not fully visible in the excerpt reviewed.
  • Teams relying on EN ISO 11137-1 or EN ISO 14155 should note that EN ISO 11137-1:2026 and EN ISO 14155:2026 are the superseding standards.
  • Quality and regulatory staff should review whether their conformity routes for sterilization, biological evaluation, reprocessing and electrical equipment still rest on standards being replaced, since the presumption of conformity depends on the published references.

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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