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Medicinal products and medical devices in clinical trials conduct and disclosure

Authors: Raquel Billiones, Kathy B. Thomas

“Medicinal products and medical devices are different species…they live in parallel universes” according to a medical device expert. But is it really so? This article challenges that notion by comparing the Clinical Trial Regulation EU No. 536/2014 (CTR) and the EU Medical Device Regulation 2017/745 (MDR) in the context of clinical studies and public disclosure. Despite some fundamental differences, similarities and overlaps in the requirements and details between the CTR and MDR are evident. There is also a clear aim for the electronic databases, as described in the two regulations, to be interoperable. This high level comparison of the CTR and MDR shows that while the requirements of the two regulations have been aligned and are very similar, their impact on the respective industries is quite different.

Medical Writing. 2019;28(2):74–80

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