(1)

In accordance with Article 8(1) of Regulation (EU) 2017/746 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) 2017/746 replaced Directive 98/79/EC of the European Parliament and of the Council (3) with effect from 26 May 2022.

(3)

By Implementing Decision C(2021) 2406 (4), 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 in vitro diagnostic medical devices developed in support of Directive 98/79/EC and for the drafting of new harmonised standards in support of Regulation (EU) 2017/746 (the ‘request’).

(4)

On the basis of the request, CEN and Cenelec revised the harmonised standards EN ISO 11137-2:2015 on sterilization of health care products, EN ISO 11607-1:2020 on packaging for terminally sterilized medical devices, and EN ISO 11607-2:2020 on packaging for terminally sterilized medical devices (the ‘standards’), 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) 2017/746. This resulted in the adoption of the amendments EN ISO 11137-2:2015/A1:2023, EN ISO 11607-1:2020/A1:2023 and EN ISO 11607-2:2020/A1:2023 (the ‘amendments’).

(5)

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

(6)

The standards and the amendments satisfy the requirements which they aim to cover, and which are set out in Regulation (EU) 2017/746. It is therefore appropriate to publish the references of the standards and of the amendments in the Official Journal of the European Union.

(7)

The Annex to Commission Implementing Decision (EU) 2021/1195 (5) lists the references of harmonised standards drafted in support of Regulation (EU) 2017/746.

(8)

In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/746 are listed in one act, the references of the standards and of the amendments should be included in Implementing Decision (EU) 2021/1195.

(9)

Implementing Decision (EU) 2021/1195 should therefore be amended accordingly.

(10)

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,