Commission Implementing Decision (EU) 2020/437
of 24 March 2020
on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC
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 , and in particular Article 10(6) thereof,
Whereas:
(1)
In accordance with Article 5(1) of Council Directive 93/42/EEC , Member States are to presume compliance with the essential requirements referred to in Article 3 of that Directive in respect of medical devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the Official Journal of the European Union.
(2)
By letters BC/CEN/CENELEC/09/89 of 19 December 1991, M/023 - BC/CEN/03/023/93-08 of 5 August 1993 and M/295 of 9 September 1999, the Commission made requests to the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) for the drafting of new harmonised standards and the revision of existing harmonised standards in support of Directive 93/42/EEC.
(3)
On the basis of the request M/295 of 9 September 1999, CEN revised the harmonised standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011, the references of which have been published in the Official Journal of the European Union , in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019.
(4)
The Commission together with CEN has assessed whether standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 comply with the request.
(5)
The harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.
(6)
The harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 replace the harmonised standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011 respectively. It is therefore necessary to withdraw the references of standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011 from the Official Journal of the European Union.
(7)
On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN revised the harmonised standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and EN ISO 13485:2016, the references of which have been published in the Official Journal of the European Union , in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018.
(8)
The Commission together with CEN has assessed whether standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 comply with the request.
(9)
The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards and of the corrigendum in the Official Journal of the European Union.
(10)
The harmonised standard EN ISO 13408-2:2018 and the corrigendum EN ISO 13485:2016/AC:2018 replace the harmonised standard EN ISO 13408-2:2011 and the corrigendum EN ISO 13485:2016/AC:2016 respectively. It is therefore necessary to withdraw the reference of standard EN ISO 13408-2:2011 and of corrigendum EN ISO 13485:2016/AC:2016 from the Official Journal of the European Union.
(11)
On the basis of the request M/023 - BC/CEN/03/023/93-08 of 5 August 1993, CEN revised the harmonised standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009, the references of which have been published in the Official Journal of the European Union , in order to include the latest technical and scientific progress. This resulted in the adoption of the harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017.
(12)
The Commission together with CEN has assessed whether standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 comply with the request.
(13)
The harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.
(14)
The harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 replace the harmonised standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009 respectively. It is therefore necessary to withdraw the references of standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009 from the Official Journal of the European Union.
(15)
On the basis of the request M/295 of 9 September 1999, CEN drafted the new harmonised standards EN 11608-7:2017, EN 13795-1:2019, EN 13795-2:2019 and EN ISO 81060-2:2019. The Commission together with CEN has assessed whether those standards comply with the request.
(16)
The harmonised standards EN 11608-7:2017, EN 13795-1:2019, EN 13795-2:2019 and EN ISO 81060-2:2019 satisfy the requirements which they aim to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.
(17)
On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN drafted the new harmonised standard EN ISO 25424:2019. The Commission together with CEN has assessed whether that standard complies with the request.
(18)
The harmonised standard EN ISO 25424:2019 satisfies the requirements, which it aims to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the reference of that standard in the Official Journal of the European Union.
(19)
In order to give manufacturers sufficient time to adapt their products to the revised specifications in standards and the corrigendum published by this Decision, it is necessary to defer the withdrawal of the reference of the standards and the corrigendum that are replaced.
(20)
In the interests of clarity and legal certainty, a complete list of references of harmonised standards drafted in support of Directive 93/42/EEC and satisfying the essential requirements they aim to cover should be published in one act. The other references of standards published in the Commission communication 2017/C 389/03 should therefore also be included in this Decision. That Communication should therefore be repealed from the date of entry into force of this Decision. However, it should continue to apply in respect of the references of the standards that are withdrawn by this Decision, given that it is necessary to defer withdrawal of those references.
(21)
In accordance with the second subparagraph of Article 120(2) of Regulation (EU) 2017/745 of the European Parliament and of the Council , certificates issued by notified bodies in accordance with Directive 93/42/EEC from 25 May 2017 are to remain valid until the end of the period indicated on the certificate, which is not to exceed five years from its issuance. They are to however become void at the latest on 27 May 2024. In accordance with the first subparagraph of Article 120(3) of Regulation (EU) 2017/745 a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 93/42/EEC and that is valid by virtue of Article 120(2), may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with Directive 93/42/EEC, and provided there are no significant changes in the design and intended purpose. This Decision should therefore apply only until 26 May 2024.
(22)
The requirements for medical devices laid down in Directive 93/42/EEC are different from those laid down in Regulation (EU) 2017/745. The standards drafted in support of Directive 93/42/EEC should therefore not be used to demonstrate conformity with requirements of Regulation (EU) 2017/745.
(23)
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 date of its publication,
HAS ADOPTED THIS DECISION:
OJ L 316, 14.11.2012, p. 12.
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
OJ C 389, 17.11.2017, p. 29.
OJ C 389, 17.11.2017, p. 29.
OJ C 389, 17.11.2017, p. 29.
Commission communication in the framework of the implementation of Council Directive 93/42/EEC concerning medical devices (2017/C 389/03) (OJ C 389, 17.11.2017, p. 29).
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).