Medical device CE marking

MDCG 2022-5 published on (MDR) borderline products: medical devices and medicinal products

2022-04

On April 26, 2022 the MDCG published the MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.

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.

The document can be downloaded in our library

Source: European Commission