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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 with effect 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 (‘the request’).
(4)On the basis of the request, CEN and CENELEC revised the harmonised standards EN 13795-1:2019 and EN 13795-2:2019 on surgical clothing and drapes, EN 14683:2019+AC:2019 on medical face masks, and EN 14180:2014 on sterilizers for medical purposes, the references 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) 2017/745.
(5)This resulted in the adoption of the harmonised standards EN 13795-1:2025, EN 13795-2:2025, EN 14683:2025 and EN 14180:2025 (‘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) 2017/745. 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) 2021/1182note lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745.
(9)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 the standards should be included in Implementing Decision (EU) 2021/1182.
(10)Implementing Decision (EU) 2021/1182 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 Councilnote. In its judgment of 5 March 2024, in Case C-588/21 Pnote, the Court of Justice 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,
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.
In the Annex to Implementing Decision (EU) 2021/1182, the following entries are added:
No | Reference of the standard33. | EN 13795-1:2025Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns34. | EN 13795-2:2025Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits35. | EN 14683:2025Medical face masks – Requirements and test methods36. | EN 14180:2025Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing
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