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 12 January 2025.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 15 December 2021.
For the European Parliament
The President
D. M. SASSOLI
For the Council
The President
A. LOGAR
(1) OJ C 283, 10.8.2018, p. 28 and OJ C 286, 16.7.2021, p. 95.
(2) Position of the European Parliament of 14 February 2019 (OJ C 449, 23.12.2020, p. 638) and position of the Council at first reading of 9 November 2021 (OJ C 493, 8.12.2021, p. 1). Position of the European Parliament of 14 December 2021 (not yet published in the Official Journal).
(3) OJ C 438, 6.12.2014, p. 12.
(4) OJ C 421, 17.12.2015, p. 2.
(5) OJ C 269, 23.7.2016, p. 31.
(6) OJ C 269 I, 7.7.2021, p. 3.
(7) OJ C 263, 25.7.2018, p. 4.
(8) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(9) 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).
(10) 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).
(11) 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).
(12) OJ L 123, 12.5.2016, p. 1.
(13) 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).
(14) 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).
(15) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(16) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
(17) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
ANNEX I
Dossier specifications for medicinal products
The dossier referred to in Article 9(2) of this Regulation shall for medicinal products include the following information:
(a)
the clinical safety and efficacy data included in the submission file to the European Medicines Agency;
(b)
all up-to-date published and unpublished information, data, analyses and other evidence as well as study reports and study protocols and analysis plans from studies with the medicinal product for which the health technology developer was a sponsor and all available information on ongoing or discontinued studies with the medicinal product for which the health technology developer is a sponsor or otherwise financially involved, and corresponding information about studies by third parties if available, relevant to the assessment scope as set out in accordance with Article 8(6), including the clinical study reports and clinical study protocols if available to the health technology developer;
(c)
HTA reports on the health technology subject to the joint clinical assessment;
(d)
information on studies based on registries;
(e)
if a health technology has been subject to a joint scientific consultation, the explanation from the health technology developer on any deviation from the recommended evidence;
(f)
the characterisation of the medical condition to be treated, including the target patient population;
(g)
the characterisation of the medicinal product under assessment;
(h)
the research question elaborated in the submission dossier, reflecting the assessment scope as set out pursuant to Article 8(6);
(i)
the description of methods used by the health technology developer in the development of the content of the dossier;
(j)
the results of information retrieval;
(k)
the characteristics of included studies;
(l)
the results on effectiveness and safety of the intervention under assessment and the comparator;
(m)
the relevant underlying documentation related to points (f) to (l).
ANNEX II
Dossier specifications for medical devices and in vitro diagnostic medical devices
1.
The dossier referred to in Article 9(2) of this Regulation shall for medical devices include:
(a)
the clinical evaluation assessment report;
(b)
the manufacturer’s clinical evaluation documentation submitted to the notified body pursuant to Section 6.1, points (c) and (d), of Annex II to Regulation (EU) 2017/745;
(c)
the scientific opinion provided by the relevant expert panels in the framework of the clinical evaluation consultation procedure;
(d)
all up-to-date published and unpublished information, data, analyses and other evidence as well as study reports and clinical study protocols and analysis plans from clinical studies with the medical device for which the health technology developer was a sponsor and all available information on ongoing or discontinued clinical studies with the medical device for which the health technology developer is a sponsor or otherwise financially involved, and corresponding information about clinical studies by third parties if available, relevant to the assessment scope as set out in accordance with Article 8(6), including the clinical study reports and clinical study protocols if available to the health technology developer;
(e)
HTA reports on the health technology subject to a joint clinical assessment, where appropriate;
(f)
data from registries concerning the medical device and information on studies based on registries;
(g)
if a health technology has been subject to a joint scientific consultation, an explanation from the health technology developer on any deviation from the recommended evidence;
(h)
the characterisation of the medical condition to be treated, including the target patient population;
(i)
the characterisation of the medical device under assessment, including its instructions for use;
(j)
the research question elaborated in the submission dossier, reflecting the assessment scope as set out pursuant to Article 8(6);
(k)
the description of methods used by the health technology developer in the development of the content of the dossier;
(l)
the results of information retrieval;
(m)
the characteristics of included studies.
2.
The dossier referred to in Article 9(2) and (3) of this Regulation shall for in vitro diagnostic medical devices include:
(a)
the performance evaluation report of the manufacturer;
(b)
the manufacturer’s performance evaluation documentation, referred to in Section 6.2 of Annex II to Regulation (EU) 2017/746;
(c)
the scientific opinion provided by the relevant expert panels in the framework of the performance evaluation consultation procedure;
(d)
the report of the Union reference laboratory.