Official Journalof the European Union

ENL series

2024/817

8.3.2024

COMMISSION IMPLEMENTING DECISION (EU) 2024/817
of 6 March 2024
amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisationof health care products and packaging for terminally sterilised medical devices(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 2012 onEuropean 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 Parliamentand of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the EuropeanParliament and of the Council (1), and in particular Article 10(6) thereof,Whereas:(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, thereferences of which have been published in the Official Journal of the European Union, are to be presumed to be inconformity with the requirements of that Regulation covered by those standards or parts thereof.

(2)

Regulation (EU) 2017/746 replaced Directive 98/79/EC of the European Parliament and of the Council (3) with effectfrom 26 May 2022.

(3)

By Implementing Decision C(2021) 2406 (4), the Commission made a request to the European Committee forStandardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) for the revisionof existing harmonised standards on in vitro diagnostic medical devices developed in support of Directive 98/79/EC
and for the drafting of new harmonised standards in support of Regulation (EU) 2017/746 (the ‘request’).

(4)

On the basis of the request, CEN and Cenelec revised the harmonised standards EN ISO 11137-2:2015 onsterilization of health care products, EN ISO 11607-1:2020 on packaging for terminally sterilized medical devices,and EN ISO 11607-2:2020 on packaging for terminally sterilized medical devices (the ‘standards’), the references ofwhich are not published in the Official Journal of the European Union, in order to take into account the latest technicaland scientific progress and the need to support the requirements of Regulation (EU) 2017/746. This resulted in theadoption of the amendments EN ISO 11137-2:2015/A1:2023, EN ISO 11607-1:2020/A1:2023 and EN ISO
11607-2:2020/A1:2023 (the ‘amendments’).

(5)

The Commission, together with CEN and Cenelec, has assessed whether the standards and the amendments complywith the request.

(1) OJ L 316, 14.11.2012, p. 12, ELI: http://data.europa.eu/eli/reg/2012/1025/oj(2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices andrepealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176, ELI: http://data.europa.eu/eli/reg/
2017/746/oj).
(3) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(OJ L 331, 7.12.1998, p. 1, ELI: http://data.europa.eu/eli/dir/1998/79/oj).
(4) Commission Implementing Decision C(2021) 2406 of 14 April 2021 on a standardisation request to the European Committee forStandardization 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.

ELI: http://data.europa.eu/eli/dec_impl/2024/817/oj

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ENOJ L, 8.3.2024(6)

The standards and the amendments satisfy the requirements which they aim to cover, and which are set out inRegulation (EU) 2017/746. It is therefore appropriate to publish the references of the standards and of theamendments 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
drafted in support of Regulation (EU) 2017/746.

(8)

In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/746 arelisted in one act, the references of the standards and of the amendments should be included in Implementing
Decision (EU) 2021/1195.

(9)

Implementing Decision (EU) 2021/1195 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 suchstandard 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) 2021/1195 is amended in accordance with the Annex to this Decision.
Article 2This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 6 March 2024.

For the Commission
The President
Ursula VON DER LEYEN(5) Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical
devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council (OJ L 258, 20.7.2021, p. 50,
ELI: http://data.europa.eu/eli/dec_impl/2021/1195/oj).

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ELI: http://data.europa.eu/eli/dec_impl/2024/817/oj

ENOJ L, 8.3.2024

ANNEX

In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added:
No‘11.

Reference of the standard

EN ISO 11137-2:2015
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
EN ISO 11137-2:2015/A1:2023

12.

EN ISO 11607-1:2020
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems andpackaging systems (ISO 11607-1:2019)
EN ISO 11607-1:2020/A1:2023

13.

EN ISO 11607-2:2020
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing andassembly processes (ISO 11607-2:2019)
EN ISO 11607-2:2020/A1:2023’.

ELI: http://data.europa.eu/eli/dec_impl/2024/817/oj

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