(1)

In accordance with Article 8(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (2), devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in that Regulation.

(2)

By Implementing Decision C(2021) 2406 (3), the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) for the revision of existing harmonised standards on medical devices developed in support of Council Directives 90/385/EEC (4) and 93/42/EEC (5) (‘the request’).

(3)

On the basis of the request and, in order to take into account the latest technical and scientific progress, CEN and CENELEC revised harmonised standards EN ISO 11137-1:2015 on sterilization of health care products together with its amendment EN ISO 11137-1:2015/A2:2019 and EN ISO 14155:2020 on clinical investigation of medical devices for human subjects together with its amendment EN ISO 14155:2020/A11:2024, the references of which are published in the Official Journal of the European Union in support of Regulation (EU) 2017/745.

(4)

The revision of those standards resulted in the adoption of the superseding harmonised standards EN ISO 11137-1:2026 and EN ISO 14155:2026 (‘the superseding standards’).

(5)

Also on the basis of the request and, in order to take into account the latest technical and scientific progress, CEN and CENELEC revised harmonised standards EN ISO 4074:2015 on natural rubber latex male condoms, EN ISO 10993-6:2016 and EN ISO 10993-7:2008 together with its amendment EN ISO 10993-7:2008/A1:2022 and corrigendum EN ISO 10993-7:2008/AC:2009 on biological evaluation of medical devices, EN ISO 15883-6:2015 on washer-disinfectors, EN IEC 60601-2-22:2020 and EN 60601-2-57:2011 on medical electrical equipment and EN ISO 80369-1:2018 on small-bore connectors for liquids and gases in healthcare applications, the references of which are not published in the Official Journal of the European Union in support of Regulation (EU) 2017/745.

(6)

The revision of those standards resulted in the adoption of the new harmonised standards EN ISO 4074:2026, EN ISO 10993-6:2026, EN ISO 10993-7:2026, EN ISO 15883-6:2026, EN IEC 60601-2-22:2020 with its amendment EN IEC 60601-2-22:2020/A11:2026, EN IEC 60601-2-57:2026 with its amendment EN IEC 60601-2-57:2026/A11:2026 and EN ISO 80369-1:2026 (‘the new standards’).

(7)

The Commission has assessed, together with CEN and CENELEC, whether the superseding standards and the new standards comply with the request.

(8)

The superseding standards and the new standards satisfy the requirements which they aim to cover, and which are set out in Regulation (EU) 2017/745. It is therefore appropriate to publish the references of those superseding standards and new standards in the Official Journal of the European Union.

(9)

The Annex to Commission Implementing Decision (EU) 2021/1182 (6) lists the references of harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745.

(10)

As the harmonised standards EN ISO 11137-1:2015 together with its amendment EN ISO 11137-1:2015/A2:2019 and EN ISO 14155:2020 together with its amendment EN ISO 14155:2020/A11:2024 have been revised, the references to their previous versions should be deleted from the Annex to Implementing Decision (EU) 2021/1182.

(11)

Implementing Decision (EU) 2021/1182 should therefore be amended accordingly.

(12)

In order to give manufacturers and other economic operators sufficient time to adapt their processes and devices that are covered by the harmonised standards EN ISO 11137-1:2015 together with its amendment EN ISO 11137-1:2015/A2:2019 and EN ISO 14155:2020 together with its amendment EN ISO 14155:2020/A11:2024, it is necessary to defer the withdrawal of the references of those harmonised standards.

(13)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its publication,