Document ID: 32023D1411
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>5.7.2023&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 170/105</p></td></tr></tbody></table>
COMMISSION IMPLEMENTING DECISION (EU) 2023/1411
of 4 July 2023
amending Implementing Decision (EU) 2021/1195 as regards a harmonised standard for sterilization of health care products
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 Council ( 1 ) , and in particular Article 10(6) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>In accordance with Article&#160;8(1) of Regulation (EU)&#160;2017/746 of the European Parliament and of the Council&#160;<a>(<span>2</span>)</a>, 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<span>Official Journal of the European Union</span>, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Regulation (EU)&#160;2017/746 replaced Directive&#160;98/79/EC of the European Parliament and of the Council&#160;<a>(<span>3</span>)</a> from 26&#160;May 2022.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>By Implementing Decision C(2021) 2406&#160;<a>(<span>4</span>)</a>, 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<span>in vitro</span> diagnostic medical devices developed in support of Directive&#160;98/79/EC and for the drafting of new harmonised standards in support of Regulation (EU)&#160;2017/746.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>On the basis of the request set out in Implementing Decision C(2021) 2406, CEN and Cenelec further revised the harmonised standard EN ISO&#160;25424:2019, the reference of which is published in the<span>Official Journal of the European Union</span>, in order to take into account the latest technical and scientific progress and the need to support the requirements of Regulation (EU)&#160;2017/746. This resulted in the adoption of amendment EN ISO&#160;25424:2019/A1:2022 to harmonised standard EN ISO&#160;25424:2019 on sterilization of health care products.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The Commission together with CEN and Cenelec has assessed whether amendment EN ISO&#160;25424:2019/A1:2022 to harmonised standard EN ISO&#160;25424:2019 complies with the request set out in Implementing Decision C(2021) 2406.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Amendment EN ISO&#160;25424:2019/A1:2022 to harmonised standard EN ISO&#160;25424:2019 satisfies the requirements which it aims to cover and which are set out in Regulation (EU)&#160;2017/746. It is therefore appropriate to publish the reference of amendment EN ISO&#160;25424:2019/A1:2022 to harmonised standard EN ISO&#160;25424:2019 in the<span>Official Journal of the European Union</span>.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>The Annex to Commission Implementing Decision (EU)&#160;2021/1195&#160;<a>(<span>5</span>)</a> lists the references of harmonised standards drafted in support of Regulation (EU)&#160;2017/746.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>In order to ensure that the references of harmonised standards drafted in support of Regulation (EU)&#160;2017/746 are listed in one act, the reference of amendment EN ISO&#160;25424:2019/A1:2022 to harmonised standard EN ISO&#160;25424:2019 should be included in Implementing Decision (EU)&#160;2021/1195.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Implementing Decision (EU)&#160;2021/1195 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>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<span>Official Journal of the European Union</span>. This Decision should therefore enter into force on the day of its publication,</p></td></tr></tbody></table>
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 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
Done at Brussels, 4 July 2023.
For the Commission
The President
Ursula VON DER LEYEN
( 1 ) OJ L 316, 14.11.2012, p. 12 .
( 2 ) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU ( OJ L 117, 5.5.2017, p. 176 ).
( 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 ).
( 4 ) 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.
( 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 ).
ANNEX
In the Annex, entry No 4 is replaced by the following:
<table><col/><col/><tbody><tr><td><p>No</p></td><td><p>Reference of the standard</p></td></tr><tr><td><p>&#8216;4.</p></td><td><p>EN ISO&#160;25424:2019</p><p>Sterilisation of health care products &#8211; Low temperature steam and formaldehyde &#8211; Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO&#160;25424:2018)</p><p>EN ISO&#160;25424:2019/A1:2022&#8217;.</p></td></tr></tbody></table>