(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 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 medical devices developed in support of Council Directives 90/385/EEC (4) and 93/42/EEC (5) (‘the request’).

(3)

On the basis of the request, CEN and CENELEC revised harmonised standards EN ISO 10993-23:2021, EN ISO 10993-12:2021 and EN ISO 10993-17:2023 on biological evaluation of medical devices, EN IEC 60601-2-83:2020 with its amendment EN IEC 60601-2-83:2020/A11:2021 on medical electrical equipment, and EN ISO 15223-1:2021 on symbols to be used with information to be supplied by the manufacturer, the references of which are published in the Official Journal of the European Union in support of Regulation (EU) 2017/745, in order to take into account the latest technical and scientific progress.

(4)

The revision of those standards resulted in the adoption of the amendments EN ISO 10993-23:2021/A1:2025 on additional in vitro reconstructed human epidermis models, EN ISO 10993-12:2021/A1:2025, EN ISO 10993-17:2023/A1:2025, EN IEC 60601-2-83:2020/A1:2025 and 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 amendments’).

(5)

Also on the basis of the request, CEN and CENELEC revised harmonised standards EN ISO 1135-4:2015 and EN ISO 1135-5:2015 on transfusion equipment for medical use, EN ISO 10993-1:2020 and EN ISO 10993-5:2009 on biological evaluation of medical devices, EN ISO 12870:2018 and EN ISO 14889:2013 with its amendment EN ISO 14889:2013/A1:2017 on ophthalmic optics, EN ISO 14607:2018 on non-active surgical implants, EN ISO 15883-1:2009 with its amendment EN ISO 15883-1:2009/A1:2014, EN ISO 15883-2:2009, EN ISO 15883-3:2009 and EN ISO 15883-7:2016 on washer-disinfectors, EN ISO 22675:2016 on prosthetics, EN ISO 23908:2013 on sharps injury protection and EN 60601-1:2006 on medical electrical equipment, the references of which are not published in the Official Journal of the European Union in support of Regulation (EU) 2017/745, in order to take into account the latest technical and scientific progress.

(6)

The revision of those standards resulted in the adoption of harmonised standards EN ISO 1135-4:2025, EN ISO 1135-5:2025, EN ISO 10993-1:2025, EN ISO 10993-5:2009 with its amendment EN ISO 10993-5:2009/A11:2025, EN ISO 12870:2025, EN ISO 14889:2025, EN ISO 14607:2025, EN ISO 15883-1:2025, EN ISO 15883-2:2025, EN ISO 15883-3:2025, EN ISO 15883-7:2025, EN ISO 22675:2025, EN ISO 23908:2025 and EN 60601-1:2006 with its amendment EN 60601-1:2006/A13:2024 (‘the standards’).

(7)

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

(8)

The amendments and the standards satisfy the requirements which they aim to cover, and which are set out in Regulation (EU) 2017/745. It is therefore appropriate to publish the references of those amendments and standards in the Official Journal of the European Union.

(9)

The Annex to Commission Implementing Decision (EU) 2021/1182 (6) lists the references of harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745.

(10)

As the harmonised standards EN ISO 10993-23:2021, EN ISO 10993-12:2021, EN ISO 10993-17:2023, EN IEC 60601-2-83:2020 with its amendment EN IEC 60601-2-83:2020/A11:2021 and EN ISO 15223-1:2021 have been amended, the reference to their previous versions should be deleted from the Annex to Implementing Decision (EU) 2021/1182.

(11)

Implementing Decision (EU) 2021/1182 should therefore be amended accordingly.

(12)

In order to give manufacturers and other economic operators sufficient time to adapt their processes and devices that are covered by harmonised standards EN ISO 10993-23:2021, EN ISO 10993-12:2021, EN ISO 10993-17:2023, EN IEC 60601-2-83:2020 with its amendment EN IEC 60601-2-83:2020/A11:2021 and EN ISO 15223-1:2021, it is necessary to defer the withdrawal of the references of those harmonised standards. In particular, for EN ISO 15223-1:2021, it is necessary to allow for a period of 5 years, as information provided by the sectorial interested parties in the Subgroup on 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 (7).

(13)

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,