(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 covered by those standards or parts thereof set out in that Regulation.

(2)

By Implementing Decision C(2021) 2406 (3), 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 of the European Parliament and the Council (4) (‘the request’).

(3)

On the basis of the request and, in order to take into account the latest technical and scientific progress, CEN and Cenelec revised the harmonised standard EN ISO 11137-1:2015 on sterilization of health care products together with its amendment EN ISO 11137-1:2015/A2:2019, the reference of which is published in the Official Journal of the European Union in support of Regulation (EU) 2017/746.

(4)

The revision of that standard resulted in the adoption of the superseding harmonised standard EN ISO 11137-1:2026 (‘the superseding standard’).

(5)

The Commission has assessed, together with CEN and Cenelec, whether the superseding standard complies with the request.

(6)

The superseding standard satisfies the requirements which it aims to cover, and which are set out in Regulation (EU) 2017/746. It is therefore appropriate to publish the reference of the superseding standard 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 for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746.

(8)

As the harmonised standard EN ISO 11137-1:2015 together with its amendment EN ISO 11137-1:2015/A2:2019 has been revised, the reference to its previous version should be deleted from the Annex to Implementing Decision (EU) 2021/1195.

(9)

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

(10)

In order to give manufacturers and other economic operators sufficient time to adapt their processes and devices that are covered by the harmonised standard EN ISO 11137-1:2015 together with its amendment EN ISO 11137-1:2015/A2:2019, it is necessary to defer the withdrawal of the reference of that harmonised standard.

(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,