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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 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) 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 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 revised harmonised standards EN 285:2015 and EN ISO 14971:2019, 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 to adapt them to the requirements of Regulation (EU) 2017/745. This resulted in the adoption of the revised harmonised standard EN 285:2015+A1:2021 on sterilisation and of the amendment EN ISO 14971:2019/A11:2021 to harmonised standard EN ISO 14971:2019 on application of risk management to medical devices.
(5) The Commission together with CEN and Cenelec has assessed whether harmonised standards EN 285:2015+A1:2021 and EN ISO 14971:2019, as amended by EN ISO 14971:2019/A11:2021, comply with the request set out in Implementing Decision C(2021) 2406.
(6) Harmonised standards EN 285:2015+A1:2021 and EN ISO 14971:2019, as amended by EN ISO 14971:2019/A11:2021, 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 harmonised standards EN 285:2015+A1:2021 and EN ISO 14971:2019 and of its amendment in the Official Journal of the European Union.
(7) The Annex to Commission Implementing Decision (EU) 2021/1182 (6) 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 harmonised standards EN 285:2015+A1:2021 and EN ISO 14971:2019 and of its amendment should be included in Implementing Decision (EU) 2021/1182.
(9) The references of harmonised standard EN ISO 13485:2016 on quality management systems and its amendment EN ISO 13485:2016/A11:2021 are published by Implementing Decision (EU) 2021/1182. However, that publication does not include the reference of the corrigendum to that standard – EN ISO 13485:2016/AC:2018. The corrigendum corrects only formal aspects of the European foreword and of the informative annexes, without affecting the substance of the harmonised standard. Harmonised standard EN ISO 13485:2016 as amended by EN ISO 13485:2016/A11:2021 and corrected by EN ISO 13485:2016/AC:2018 satisfies the requirements which it aims to cover and which are set out in Regulation (EU) 2017/745. In order to ensure that corrections made by EN ISO 13485:2016/AC:2018 apply for the purposes of the presumption of conformity with the relevant requirements of Regulation (EU) 2017/745, it is necessary to include the reference of that corrigendum in Implementing Decision (EU) 2021/1182. For reasons of legal certainty, the reference of corrigendum EN ISO 13485:2016/AC:2018 should be published in the Official Journal of the European Union with retroactive effect.
(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,
HAS ADOPTED THIS DECISION:
The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
Point 1 of the Annex shall apply from 5 January 2022.
Done at Brussels, 11 May 2022.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 316, 14.11.2012, p. 12.
(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).
(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).
(4) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
(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.
(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).
The Annex to Implementing Decision (EU) 2021/1182 is amended as follows:
(1) entry No 10 is replaced by the following:
No | Reference of the standard
10. | EN ISO 13485:2016 | Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
| EN ISO 13485:2016/AC:2018 |
| EN ISO 13485:2016/A11:2021 |
(2) the following entries are added:
No | Reference of the standard
15. | EN 285:2015+A1:2021 | Sterilization – Steam sterilizers – Large sterilizers |
16. | EN ISO 14971:2019 | Medical devices – Application of risk management to medical devices (ISO 14971:2019) |
| EN ISO 14971:2019/A11:2021 |
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
60.60 Standard published