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Licensed Unlicensed Requires Authentication Published by De Gruyter May 30, 2022

The novelties of the regulation on health technology assessment, a key achievement for the European union health policies

Alice Pisapia, Giuseppe Banfi and Rossella Tomaiuolo


Health technology assessment is a key tool for ensuring healthcare quality, accessibility, and sustainability. The novel European Union (EU) Health Technology Assessment (HTA) regulation of 15 December 2021, in harmonizing the laws of the Member States about the procedures and criteria for the evaluation of health technologies (i.e., medical devices and in vitro diagnostic tools), constitutes a significant achievement in the definition of EU health policies. On the one hand, for the European Union, it constitutes an essential driving force for the development of a competitive market for health technologies and, on the other, for European citizens, it guarantees the application of superordinate safety and quality standards with an impact positive on access to health technologies, including expressly also in vitro diagnostic medical devices classified in class D by art. 47 of Reg. (EU) 2017/746. As pointed out by the European Commissioner for Healthcare, the regulation identifies a new way for the Member States to cooperate on healthcare matters in the Union. The clinical efficacy and safety of drugs and devices are legal assets that today find their protection in a binding and directly applicable regulatory instrument, superordinate in the hierarchy of sources. Implementing the regulation will also be essential to achieve the objectives of the Union’s pharmaceutical strategy and the European plan to fight cancer. The novel HTA European regulation, applicable from January 2025, will ensure inclusion and transparency in evaluating health technologies and increase the predictability of decisions for both Member State authorities and industry.

Corresponding author: Giuseppe Banfi, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy; and Vita-Salute San Raffaele University, Milan, Italy, E-mail:

  1. Research funding: None declared.

  2. Author contributions: G.B. devised the manuscript; A.P. drew up the manuscript; G.B. and R.T examined the manuscript critically for important intellectual content. All authors have approved the final version to be published. All authors are responsible for all aspects of the work in ensuring that matters relating to the accuracy or integrity of any part of the work is properly researched and resolved.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.


1. Luhnen, M, Ormstad, SS, Willemsen, A, Schreuder-Morel, C, Helmink, C, Ettinger, S, et al.. Developing a quality management system for the European network for health technology assessment (EUnetHTA): toward European HTA collaboration. Int J Technol Assess Health Care 2021;37:e59. in Google Scholar PubMed

2. Website of the European Union. Available from [Accessed 9 May 2022].Search in Google Scholar

3. Website of the European Union. Available from [Accessed 9 May 2022].Search in Google Scholar

4. Website of the European Union. Available from [Accessed 9 May 2022].Search in Google Scholar

5. Website of the European Union. Available from [Accessed 9 May 2022].Search in Google Scholar

6. Plebani, M. Laboratory medicine in the COVID-19 era: six lessons for the future. Clin Chem Lab Med 2021;59:1035–45. in Google Scholar PubMed

7. Tomaiuolo, R, Derrico, P, Ritrovato, M, Locatelli, M, Milella, F, Restelli, U, et al.. COVIDIAGNOSTIX: health technology assessment of serological tests for SARS-CoV-2 infection. Int J Technol Assess Health Care 2021;37:e87. in Google Scholar PubMed

8. Website of the European Union. Available from [Accessed 9 May 2022].Search in Google Scholar

9. Campbell, CA, Horvath, AR. Harmonization of critical result management in laboratory medicine. Clin Chim Acta 2014;432:135–47. in Google Scholar PubMed

10. Ferraro, S, Biganzoli, EM, Castaldi, S, Plebani, M. Health Technology Assessment to assess the value of biomarkers in the decision-making process. Clin Chem Lab Med 2022;60:647–54. in Google Scholar PubMed

Received: 2022-03-10
Accepted: 2022-05-19
Published Online: 2022-05-30
Published in Print: 2022-07-26

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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