Commission updates harmonised standards for medical devices and defers old withdrawals

The European Commission has updated the list of harmonised standards that give medical devices a presumption of conformity with Regulation (EU) 2017/745, adding seven new references and replacing two older ones. The change is made by Commission Implementing Decision (EU) 2026/2479 of 9 November 2026, published in the Official Journal of the European Union (L series, 10 November 2026). The decision enters into force on the day of its publication.

The legal basis is Article 10(6) of Regulation (EU) No 1025/2012 on European standardisation. Under Article 8(1) of Regulation (EU) 2017/745, devices conforming to harmonised standards whose references are published in the Official Journal are presumed to conform with the requirements those standards cover. The Commission acted on the standardisation request issued to CEN and CENELEC by Implementing Decision C(2021) 2406 of 14 April 2021, and after assessing with both bodies that the revised standards satisfy the request.

Two superseding standards replace older versions

CEN and CENELEC revised two standards already published in support of Regulation (EU) 2017/745, producing new versions that supersede them:

• EN ISO 11137-1:2026 on sterilisation of health care products — radiation — replacing EN ISO 11137-1:2015 and its amendment EN ISO 11137-1:2015/A2:2019.
• EN ISO 14155:2026 on clinical investigation of medical devices for human subjects — good clinical practice, replacing EN ISO 14155:2020 and its amendment EN ISO 14155:2020/A11:2024.

In the Annex to Implementing Decision (EU) 2021/1182, entry No 3 and entry No 39 are deleted and the new references are inserted as entries 3a and 39a respectively.

Seven new references added to the list

The decision also publishes references for standards that were not previously listed in the Official Journal under the medical devices Regulation. They are added as entries 66 to 72:

• EN ISO 4074:2026 — natural rubber latex male condoms, requirements and test methods.
• EN ISO 10993-6:2026 — biological evaluation of medical devices, tests for local effects after implantation.
• EN ISO 10993-7:2026 — biological evaluation of medical devices, ethylene oxide sterilisation residuals.
• EN ISO 15883-6:2026 — washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment.
• EN IEC 60601-2-22:2020 with its amendment EN IEC 60601-2-22:2020/A11:2026 — laser equipment for surgical, cosmetic, therapeutic and diagnostic use.
• EN IEC 60601-2-57:2026 with its amendment EN IEC 60601-2-57:2026/A11:2026 — non-laser light source equipment for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use.
• EN ISO 80369-1:2026 — small-bore connectors for liquids and gases in healthcare applications, general requirements.

Deferred withdrawal gives industry until May 2028

Because manufacturers and other economic operators need time to adapt their processes and devices, the Commission deferred the withdrawal of the references to the previous sterilisation and clinical investigation standards. Under Article 2, points (1) and (3) of the Annex — the deletions of the old entries — apply only from 10 May 2028. Until then, the superseded standards coexist in the list with their replacements, so conformity with either version can still support the presumption of conformity.

Parallel move for in vitro diagnostics

On the same day the Commission adopted Implementing Decision (EU) 2026/2481, which amends Implementing Decision (EU) 2021/1195 in the same sense for in vitro diagnostic medical devices under Regulation (EU) 2017/746. That decision publishes the reference of EN ISO 11137-1:2026 for sterilisation of health care products, replacing EN ISO 11137-1:2015 and its amendment EN ISO 11137-1:2015/A2:2019.

The immediate effect is that manufacturers, notified bodies and test laboratories can already cite the 2026 editions of these standards in technical documentation, conformity assessment and CE marking files, while the two-year transition window shields ongoing sterilisation-validation and clinical-investigation programmes from disruption. Patients and users stand to gain from updated requirements on condoms, implant biocompatibility, ethylene oxide residues and connector safety.

Source: Official Journal of the European Union, L series, No 2026/2479, 10 November 2026 (official reference: CELEX:L_202602479).