Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

MDCG Guidance on Borderline Products

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed documents-and-other-guidance_en#mdcg-work-in-progress

The Organisation for Professionals in Regulatory Affairs

9

The regulatory framework is evolving…

https://www.ema.europa.eu/en/human regulatory/overview/medical-devices

The Organisation for Professionals in Regulatory Affairs

10

5