(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 of that Regulation covered by those standards or parts thereof.

(2)

Regulation (EU) 2017/745 replaced Council Directives 90/385/EEC (3) and 93/42/EEC (4) with effect from 26 May 2021.

(3)

By Implementing Decision C(2021) 2406 (5), 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 Directives 90/385/EEC and 93/42/EEC, and for the drafting of new harmonised standards in support of Regulation (EU) 2017/745 (‘the request’).

(4)

On the basis of the request, CEN and Cenelec revised the harmonised standards EN ISO 7197:2009 on neurosurgical implants, EN ISO 10993-4:2017 on biological evaluation of medical devices, EN ISO 14155:2020 on clinical investigation of medical devices for human subjects, EN ISO 14630:2012, EN ISO 21535:2009 and EN ISO 21536:2009 on non-active surgical implants, EN ISO 17665-1:2006 on sterilization of health care products, and EN ISO 18562-1:2020, EN ISO 18562-2:2020, EN ISO 18562-3:2020 and EN ISO 18562-4:2020 on biocompatibility evaluation of breathing gas pathways in healthcare applications, and drafted a new harmonised standard 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 order to take into account the latest technical and scientific progress and the need to support the requirements of Regulation (EU) 2017/745.

(5)

The revision of those standards resulted in the adoption of harmonised standards EN ISO 7197:2024, EN ISO 14630:2024, EN ISO 17665:2024, EN ISO 18562-1:2024, EN ISO 18562-2:2024, EN ISO 18562-3:2024, EN ISO 18562-4:2024, EN ISO 21535:2024, EN ISO 21536:2024 and EN ISO 80369-2:2024 (‘the standards’), and of the amendments to harmonised standards EN ISO 10993-4:2017/A1:2025 and EN ISO 14155:2020/A11:2024 (‘the amendments’).

(6)

The Commission together with CEN and Cenelec has assessed whether the standards and the amendments comply with the request.

(7)

The standards and the amendments 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 the standards and of the amendments in the Official Journal of the European Union.

(8)

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

(9)

In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/745 are listed in one act, the references of the standards and of the amendments should be included in Implementing Decision (EU) 2021/1182.

(10)

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

(11)

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,