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Commission amends MDR harmonised standards list for sterilisation, biocompatibility, condoms and other device areas

🇪🇺 EUR-Lex · Tue 10 Nov 2026

Implementing Decision (EU) 2026/2479 updates the list of harmonised standards under the Medical Devices Regulation across seven product and process areas.

The European Commission has adopted Implementing Decision (EU) 2026/2479, dated 9 November 2026, amending Implementing Decision (EU) 2021/1182. That earlier decision sets out the harmonised standards drawn up in support of the Medical Devices Regulation (EU) 2017/745 (MDR).

The amendment covers standards for the sterilisation of health care products, clinical investigation of medical devices for human subjects, natural rubber latex male condoms, and biological evaluation of medical devices. It also covers washer-disinfectors, medical electrical equipment, and small-bore connectors for liquids and gases in healthcare applications.

The material available does not say which individual standards or versions have been added, replaced or withdrawn. It also gives no transition dates. Readers will need to consult the full text of the decision in the Official Journal to see the specific changes.

By way of context, harmonised standards whose references are published in this way give manufacturers a route to presume conformity with the MDR requirements the standards cover, provided they apply them.

What it means for your team

  • Check the full text of Decision (EU) 2026/2479 to identify exactly which standards and versions have changed in each of the seven areas.
  • Compare your technical documentation and declarations of conformity against the updated list wherever you rely on these standards for a presumption of conformity.
  • Manufacturers of sterile products, reusable devices, condoms, electrically powered devices and connectors should prioritise the review, as should sponsors of clinical investigations.
  • Look for transition arrangements in the decision itself, as none are specified in the information available.

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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