Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products

Official Journal EN of the European Union L series 2024/2631 9.10.2024 COMMISSION IMPLEMENTING DECISION (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products (Text with EEA relevance) 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 2012on 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 Council(1), 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 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 of that Regulation covered by those standards or parts thereof.

(2) Regulation (EU) 2017/745 replaced Council Directives 90/385/EEC(3) and 93/42/EEC(4)with effect from 26 May

2021.

(3) By Implementing Decision C(2021) 2406(5), 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 standard EN ISO 13408-1:2015 for aseptic processing of health care products, 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.

(5) This resulted in the adoption of the harmonised standard EN ISO 13408-1:2024 (‘the standard’).

(1) OJ L 316, 14.11.2012, p. 12, ELI: http://data.europa.eu/eli/reg/2012/1025/oj.

(2) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj).

(3) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17, ELI: http://data.europa.eu/eli/dir/1990/385/oj).

(4) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1, ELI: http://data.europa.eu/eli/ dir/1993/42/oj).

(5) Commission Implementing Decision C(2021) 2406 of 14 April 2021 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation

(EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation

(EU) 2017/746 of the European Parliament and of the Council. Available online on: https://ec.europa.eu/growth/tools-databases/ enorm/mandate/575_en.

ELI: http://data.europa.eu/eli/dec_impl/2024/2631/oj 1/3EN OJ L, 9.10.2024

(6) The Commission together with CEN and CENELEC has assessed whether the standard complies with the request.

(7) The standard satisfies the requirements which it aims to cover, and which are set out in Regulation (EU) 2017/745. It is therefore appropriate to publish the reference of the standard in the Official Journal of the European Union.

(8) The Annex to Commission Implementing Decision (EU) 2021/1182(6)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 reference of the standard 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 Council(7). In its judgment of 5 March 2024Public.Resource.Org and Right to Know v. Commission and Others(8), the Court of Justice of the European Union 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.

Done at Brussels, 8 October 2024.

For the Commission The President Ursula VON DER LEYEN

(6) Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council (OJ L 256, 19.7.2021, p. 100, ELI: http://data.

europa.eu/eli/dec_impl/2021/1182/oj).

(7) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43, ELI: http://data.europa.eu/eli/reg/2001/1049/oj).

(8) Judgment of the Court of Justice of the European Union of 5 March 2024 Public.Resource.Org and Right to Know v. Commission and Others, C-588/21 P, ECLI:EU:C:2024:201.

2/3 ELI: http://data.europa.eu/eli/dec_impl/2024/2631/ojEN OJ L, 9.10.2024 ANNEX In the Annex to Implementing Decision (EU) 2021/1182, the following entry is added:

No Reference of the standard ‘26. EN ISO 13408-1:2024 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)’.

ELI: http://data.europa.eu/eli/dec_impl/2024/2631/oj 3/3