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New European Regulation for Medical Devices: What Is Changing?

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.

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Correspondence to Nicolas Martelli.

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Martelli, N., Eskenazy, D., Déan, C. et al. New European Regulation for Medical Devices: What Is Changing?. Cardiovasc Intervent Radiol 42, 1272–1278 (2019). https://doi.org/10.1007/s00270-019-02247-0

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Keywords

  • Medical device
  • Regulation
  • Clinical investigation
  • CE mark