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 Agency 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.
The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and medical device and medicinal product combinations.
This guidance document may be revised to reflect up-to-date scientific and technical knowledge as well as the outcomes of the regulatory discussions within the MDCG Working Group on Borderline and Classification.