New European Regulation for Medical Devices: What Is Changing?
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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.
KeywordsMedical 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.
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