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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Councilnote, and in particular Article 10(6) thereof,Whereas:
(1)In accordance with Article 8(1) of Regulation (EU) 2017/745 of the European Parliament and of the Councilnote, 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/EECnote and 93/42/EECnote from 26 May 2021.
(3)By Implementing Decision C(2021) 2406note, 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.
(4)On the basis of the request set out in Implementing Decision C(2021) 2406, CEN and Cenelec further revised the harmonised standard EN ISO 25424:2019, the reference of which is published in the Official Journal of the European Union, and revised the harmonised standard EN ISO 10993-10:2013, 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. This resulted in the adoption of amendment EN ISO 25424:2019/A1:2022 to harmonised standard EN ISO 25424:2019 on sterilization of health care products and of the revised harmonised standard EN ISO 10993-10:2023 on biological evaluation of medical devices.
(5)The Commission together with CEN and Cenelec has assessed whether amendment EN ISO 25424:2019/A1:2022 to harmonised standard EN ISO 25424:2019 and harmonised standard EN ISO 10993-10:2023 comply with the request set out in Implementing Decision C(2021) 2406.
(6)Amendment EN ISO 25424:2019/A1:2022 to harmonised standard EN ISO 25424:2019 and harmonised standard EN ISO 10993-10:2023 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 amendment EN ISO 25424:2019/A1:2022 to harmonised standard EN ISO 25424:2019 and of harmonised standard EN ISO 10993-10:2023 in the Official Journal of the European Union.
(7)The Annex to Commission Implementing Decision (EU) 2021/1182note lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745.
(8)In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/745 are listed in one act, the references of amendment EN ISO 25424:2019/A1:2022 to harmonised standard EN ISO 25424:2019 and of harmonised standard EN ISO 10993-10:2023 should be included in Implementing Decision (EU) 2021/1182.
(9)Implementing Decision (EU) 2021/1182 should therefore be amended accordingly.
(10)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,
HAS ADOPTED THIS DECISION:
Article 1#
The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.
Article 2#
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
(1)entry No 5 is replaced by the following:No | Reference of the standard5. | EN ISO 25424:2019Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018)EN ISO 25424:2019/A1:2022;
(2)the following entry is added:No | Reference of the standard17. | EN ISO 10993-10:2023Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021).
The Annex is amended as follows:
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