(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, CEN and CENELEC revised the harmonised standard EN ISO 15223-1:2021 on symbols to be used with information to be supplied by the manufacturer, the reference of which is published in the Official Journal of the European Union in support of Regulation (EU) 2017/746, in order to take into account the latest technical and scientific progress.

(4)

The revision of this standard resulted in the adoption of the amendment EN ISO 15223-1:2021/A1:2025 on addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific (‘the amendment’).

(5)

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

(6)

The amendment 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 amendment 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 15223-1:2021 has been amended, 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 15223-1:2021, it is necessary to defer the withdrawal of the reference of that harmonised standard, to allow for a period of 5 years, as information provided by the sectorial interested parties in the Subgroup of Standards of the Medical Device Coordination Group shows the significant impact on economic operators in terms of costs and timing to implement labelling changes in manufacturing and distribution of devices, taking into account the processes involved, both at EU and international levels (6).

(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,