This document is an excerpt from the EUR-Lex website
Regulation (EU) 2021/2282 on health technology assessment
Health technology assessment
Health technology assessment (HTA) is an evidence-based scientific process that enables national authorities to assess the relative effectiveness of new or existing health technologies. It focuses in particular on the added value of a health technology compared to other new or existing technologies.
The regulation sets out rules on the use of common methods, procedures and tools for HTA throughout the European Union (EU), specifically:
Scope
Coordination group
Member State obligations
Regulation (EU) 2021/2282 entered into force on 11 January 2022. It will apply from 12 January 2025.
For further information, see:
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, pp. 1–32).
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, pp. 1–175).
Successive amendments to Regulation (EU) 2017/745 have been incorporated in the original text. This consolidated version is of documentary value only.
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, pp. 176–332).
See consolidated version.
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, pp. 45–65).
See consolidated version.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community 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, pp. 1–33).
See consolidated version.
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, pp. 67–128).
See consolidated version.
last update 28.04.2022