MDCG 2022-5 rev.1 – Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices – October 2024

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.

Read the news announcement published by EC Directorate-General for Health and Food Safety on 29 October 2024.