Questions and Answers document updated version has been released on 21.10.2019 by the European Medicines Agency (EMA).
Notified bodies should seek authorisation to the EMA or NCAs for marketing authorisation of medical devices incorporating a medicinal substance, devices that are composed of substances or of combinations of substances that are systematically absorbed by the body and for companion diagnostics.
The updated version of the documents is structured as a Q&A to clarify some critical issues regarding the status of these peculiar devices, together with administration devices. In particular, this update focuses on medicinal products
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