Defining Medical Device vs Medicinal Product | MDCG 2022-5

The Medical Device Coordination Group (MDCG) has released a revision of the MDCG 2022-5 guidance, which clarifies the regulatory boundaries between a medical device and a medicinal product under Regulation (EU) 2017/745 on medical devices. 

In this latest version (Rev. 1, October 2024), updates are made specifically to Section 1.2.6.1, focusing on products intended for cleaning, disinfection, or sterilization of medical devices. Notably, the text previously highlighted in red has been removed, while the core guidance remains unchanged. 

Updated Section Overview

This minor but meaningful change helps to reinforce the scope of products governed by the regulation, providing clarity to manufacturers and stakeholders in the industry. 

Access the updated MDCG 2022-5 Guidance on the borderline between medical device vs medicinal product here.

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