1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
2. It shall apply from 26 May 2022.
3. By way of derogation from paragraph 2:
(a)
Article 27(3) and Article 51(5) shall apply from 27 November 2023;
(b)
Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34;
(c)
Article 97 shall apply from 26 May 2018;
(d)
Article 100 shall apply from 25 November 2020;
(e)
for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027;
(f)
without prejudice to the obligations on the Commission pursuant to Article 34 of Regulation (EU) 2017/745, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1) of that Regulation, Eudamed is not fully functional on 26 May 2022, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) of that Regulation. The provisions referred to in the preceding sentence are:
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the second sentence of Article 36(2),
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the second subparagraph of Article 40(12),
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points (d) and (e) of Article 42(7),
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Articles 66 to 73,
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paragraphs 1 to 13 of Article 74,
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Articles 75 to 77,
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Articles 82 and 83,
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Article 84(5) and (7) and the third subparagraph of Article 84(8),
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Article 88(4), (7) and (8),
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Article 90(2) and (4),
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the last sentence of Article 92(2),
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the second sentence of the first subparagraph of Article 110(3).
Until Eudamed is fully functional the corresponding provisions of Directive 98/79/EC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding performance studies, vigilance reporting, registration of devices and economic operators, and certificate notifications.
(g)
The procedure set out in Article 74 shall, apply from 26 May 2027 without prejudice to Article 74(14).
(h)
Article 110(10) shall apply from 26 May 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 5 April 2017.
For the European Parliament
The President
A. TAJANI
For the Council
The President
I. BORG
(1) Opinion of 14 February 2013 (OJ C 133, 9.5.2013, p. 52).
(2) Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of the Council at first reading of 7 March 2017 (not yet published in the Official Journal).
(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) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79).
(5) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).
(6) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(7) Regulation (EU) No 1025/2012 of 25 October 2012 of the European Parliament and of the Council 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 (OJ L 316, 14.11.2012, p. 12).
(8) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(9) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(10) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(11) Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C-400/09 and C-207/10, ECLI:EU:C:2011:519.
(12) 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 (see page 1 of this Official Journal).
(13) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(14) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(15) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(16) Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010. p. 33).
(17) OJ L 123, 12.5.2016, p. 1.
(18) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(19) 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)
(20) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1)
(21) OJ C 358, 7.12.2013, p. 10.
(22) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (OJ L 157, 9.6.2006, p. 24).
(23) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
(24) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
(25) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(26) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
ANNEXES
I
General safety and performance requirements
II
Technical documentation
III
Technical documentation on post-market surveillance
IV
EU declaration of conformity
V
CE marking of conformity
VI
Information to be submitted upon the registration of devices and economic operators in accordance with Articles 26(3) and 28, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 25 and 26 and the UDI system
VII
Requirements to be met by notified bodies
VIII
Classification rules
IX
Conformity assessment based on a quality management system and on assessment of technical documentation
X
Conformity assessment based on type examination
XI
Conformity assessment based on production quality assurance
XII
Certificates issued by a notified body
XIII
Performance evaluation, performance studies and post-market performance follow-up
XIV
Interventional clinical performance studies and certain other performance studies
XV
Correlation table
ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS