Guidance MDCG 2022-5 on borderline between medical devices and medicinal products under Regulation (EU) 2017/745

The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-5 which aims to establish the demarcation between the two legal frameworks established in Regulation (EU) 2017/745 on medical devices and Directive 2001/83/EC on medicinal products for human use.

This guidance provides explanations, definitions and examples clarifying the borderline between medical devices and medicinal products. Chapters are dedicated to herbal products, substance-based devices and medical devices and medicinal product combinations

This document, developed by an expert working group, aims to support a uniform implementation of the MDR across the EU and 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 of these devices.

DOWLOAD THE GUIDANCE MDCG 2022-5