CardioVascular and Interventional Radiology

, Volume 42, Issue 9, pp 1272–1278 | Cite as

New European Regulation for Medical Devices: What Is Changing?

  • Nicolas MartelliEmail author
  • Déborah Eskenazy
  • Carole Déan
  • Judith Pineau
  • Patrice Prognon
  • Gilles Chatellier
  • Marc Sapoval
  • Olivier Pellerin



The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice.

Materials and Methods

In this paper, we describe the major transformation that the MDR brings to the medical devices sector, with a focus on clinical evaluations and clinical investigations.


This regulation significantly tightens controls to ensure that devices are safe and effective. In addition, equivalence to already existing devices, which allowed an accelerated access to the market, will now be possible only in some cases. Furthermore, post-marketing clinical follow-up is extended under the MDR and is required for all devices. These new requirements will probably lead to a dramatic increase in the number of clinical investigations and also to a delay in the availability of certain devices on the market.


In the coming years, interventional radiologists are likely to be affected by these changes in their daily practice, in terms of medical device availability and/or in terms of increased involvement in clinical investigations.


Medical device Regulation Clinical investigation CE mark 


Compliance with Ethical Standards

Conflict of interest

On behalf of all authors, the corresponding author states that there is no conflict of interest.


  1. 1.
    Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of The European Communities L 169, 12.7.1993; 1–43. n.d. Accessed 21 Oct 2018.
  2. 2.
    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. vol. OJ L. 1990.Google Scholar
  3. 3.
    Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. vol. OJ L. 1998.Google Scholar
  4. 4.
    French-Mowat E, Burnett J. How are medical devices regulated in the European Union? J R Soc Med. 2012;105:S22–S28. Scholar
  5. 5.
    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. vol. 117. 2017.Google Scholar
  6. 6.
    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. vol. 117. 2017.Google Scholar
  7. 7.
    Miller V, Clark E. The European Union: a guide to terminology, procedures and sources. SN/IA/3689. House of Commons Library; 2010.Google Scholar
  8. 8.
    Article 288 of the Treaty on the Functioning of the European Union, Official Journal C 326, 26.10.2012; 1–390.Google Scholar
  9. 9.
    Migliore A. On the new regulation of medical devices in Europe. Expert Rev Med Devices. 2017;14:921–3. Scholar
  10. 10.
    Bianco S, Nunziata A, Pozzoli G. Clinical investigations on medical devices, after the new European regulation (2017/745). Clin Trial Pract Open J. 2017;1:10–4.Google Scholar
  11. 11.
    Gliklich RE, Dreyer NA, Leavy MB. Registries for medical devices. Agency for Healthcare Research and Quality (US); 2014.Google Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2019

Authors and Affiliations

  1. 1.Pharmacy Department, Assistance Publique - Hôpitaux de ParisHôpital Européen Georges PompidouParisFrance
  2. 2.University of Paris-Sud, Université Paris-SaclayChâtenay-MalabryFrance
  3. 3.Vascular and Oncological Interventional Radiology Department Assistance Publique - Hôpitaux de Paris,Hôpital Européen Georges PompidouParisFrance
  4. 4.Clinical of Research Unit (URC)Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges PompidouParisFrance
  5. 5.Faculté de MédecineUniversité Paris Descartes - Sorbonne - Paris - CitéParisFrance
  6. 6.INSERM U970ParisFrance

Personalised recommendations