Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies regarding medicines used in combination with medical devices and consultation procedures for certain medical devices

Title:
Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies regarding medicines used in combination with medical devices and consultation procedures for certain medical devices

https://www.gmp-compliance.org/files/guidemgr/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf

Origin/Publisher:

EMA

Content:
This Question and Answer (Q&A) document provides practical considerations concerning the application of the medical devices and the in vitro diagnostic medical devices regulations in the context of combinations of medicinal products with medical devices.

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