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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
Review
  • 202 Downloads

Abstract

Introduction

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.

Results

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.

Conclusions

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.

Keywords

Medical device Regulation Clinical investigation CE mark 

Notes

Compliance with Ethical Standards

Conflict of interest

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

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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

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