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

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

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.