Navigating the border: Medical Devices vs. Medical Products

The latest guidance document MDCG 2022-5 Rev. 1 is a key resource for stakeholders working under Regulation (EU) 2017/745.

Developed by the Medical Devices Coordination Group (MDCG) and approved by representatives from all EU Member States, these guidelines aim to clarify the sometimes nuanced distinction between medical devices and medicinal products.