(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 standard EN ISO 13408-1:2015 for aseptic processing of health care products, the reference of which is 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)

This resulted in the adoption of the harmonised standard EN ISO 13408-1:2024 (‘the standard’).

(6)

The Commission together with CEN and CENELEC has assessed whether the standard complies with the request.

(7)

The standard satisfies the requirements which it aims to cover, and which are set out in Regulation (EU) 2017/745. It is therefore appropriate to publish the reference of the standard 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 reference of the standard 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.

(12)

The harmonised standards adopted in response to standardisation requests may be subject to access to documents requests in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council (7). In its judgment of 5 March 2024Public.Resource.Org and Right to Know v. Commission and Others (8), the Court of Justice of the European Union recognised that there is an overriding public interest, within the meaning of Article 4(2) of Regulation (EC) No 1049/2001, justifying the disclosure of harmonised standards,