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 with and integral or co-packaged medical devices.
Section 1 addresses the regulatory framework that a product incorporating both medicinal product and medical device would fall under, drawing a distinction between ancillary and principal action of the medicinal substance as well as the criteria of choice of a Notified body required to fulfil the obligations laid down in art. 117 of MDR for Marketing Authorisation.
Other clarifications follow in Section 2 on how the MDR will impact the new Marketing Authorisation applications and on the timeline to provide the Notified Body Opinion, EU Certificate or Declaration of Conformity along with the applications for such authorisations.
The document further clarifies the impact of the MDR on the already and currently authorised medicinal products with an integral Medical Device (DDCs) and clarifies that the UDI system is not applicable to such devices.
Check the Q&A revised document in full text here.
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