(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)

In 2021, 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 (3) and 93/42/EEC (4), and for the drafting of new harmonised standards in support of Regulation (EU) 2017/745 (‘the request’).

(3)

On the basis of the request, CEN and Cenelec revised harmonised standards EN 13060:2014+A1:2018 on small steam sterilizers and EN 60118-0:2015 on electroacoustics – hearing aids, and drafted a new harmonised standard on stainless steel steam boilers, in order to take into account the latest technical and scientific progress.

(4)

The revision of those standards resulted in the adoption of harmonised standards EN 13060:2025, EN 14222:2021+A1:2025 and EN IEC 60118-0:2024 (‘the standards’).

(5)

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

(6)

The 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 standards in the Official Journal of the European Union.

(7)

The Annex to Commission Implementing Decision (EU) 2021/1182 (5) lists the references of harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745.

(8)

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

(9)

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,