The demarcation between the Regulation (EU) 2017/745 on medical devices (MDR) on
the one hand and the Directive 2001/83/EC on the Community code relating to medicinal
products for human use (MPD) on the other hand is crucial for the proper implementation of these sets of legislation and their correct interpretation and enforcement. Several provisions to establish the demarcation between the two legal frameworks have been laid down in the MDR and MPD. This document provides further explanations and examples clarifying these provisions in order to support the uniform application of the MDR across the EU. It has been elaborated by a working group including experts from Member States’ competent authorities, the Commission services, European Medicines Agency1 as well as a wide range of stakeholders, and has been endorsed by the Medical Device Coordination Group (MDCG) – the governance group of medical device competent authorities at EU level…
