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New European Regulation for Medical Devices: What Is Changing?
Ist Teil von
Cardiovascular and interventional radiology, 2019-09, Vol.42 (9), p.1272-1278
Ort / Verlag
New York: Springer US
Erscheinungsjahr
2019
Link zum Volltext
Quelle
springer (창간호~2014)
Beschreibungen/Notizen
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.