Medicinal products & medicinal substances incorporated in medical devices

White papers - 22 October 2020

Medicinal products & medicinal substances incorporated in medical devices

The implementation of the European Medical Device Regulation, Regulation (EU) 2017/745 (MDR) and the publication of numerous guidelines could increase the already existing confusion about the association of medicinal product or medicinal substance with medical device. The objective of this whitepaper is to provide a support on the management of initial submission to EMA (European Medicines Agency) of such association according to version 1 of EMA Guideline recently

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