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Erschienen in: CardioVascular and Interventional Radiology 9/2019

23.05.2019 | Review

New European Regulation for Medical Devices: What Is Changing?

verfasst von: Nicolas Martelli, Déborah Eskenazy, Carole Déan, Judith Pineau, Patrice Prognon, Gilles Chatellier, Marc Sapoval, Olivier Pellerin

Erschienen in: CardioVascular and Interventional Radiology | Ausgabe 9/2019

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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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Metadaten
Titel
New European Regulation for Medical Devices: What Is Changing?
verfasst von
Nicolas Martelli
Déborah Eskenazy
Carole Déan
Judith Pineau
Patrice Prognon
Gilles Chatellier
Marc Sapoval
Olivier Pellerin
Publikationsdatum
23.05.2019
Verlag
Springer US
Erschienen in
CardioVascular and Interventional Radiology / Ausgabe 9/2019
Print ISSN: 0174-1551
Elektronische ISSN: 1432-086X
DOI
https://doi.org/10.1007/s00270-019-02247-0

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