(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 13408-1:2015 for aseptic processing of health care products, and drafted a new harmonised standard for clinical performance studies using specimens from human subjects, the reference 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.

(5)

This resulted in the adoption of the harmonised standards EN ISO 13408-1:2024 and EN ISO 20916:2024 (‘the standards’).

(6)

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

(7)

The standards 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 in the Official Journal of the European Union.

(8)

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

(9)

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 should be included in Implementing Decision (EU) 2021/1195.

(10)

Implementing Decision (EU) 2021/1195 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 (6). In its judgment of 5 March 2024Public.Resource.Org and Right to Know v. Commission and Others (7), 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,