- European Medical Device Regulations training session at IESE Business School – University of Navarra Center for Research in Healthcare Innovation Management on the 21st June 2018 to participants of the EIT Health #StarShip programme. The focus of the session was on understanding the key regulatory elements to consider in any new medical device development, from qualification viability, to requirements identification and demonstration of compliance.
- Training on the Regulation of Medical Devices organized by Fundación LEITAT on the 10th July 2018. A global view on the regulation for MDs and IVDs was provided, including the European legal framework, conformity assessment requriements and procedures, and development milestones for the CE marking of MDs and IVDs.
Brexit updates for human use medicinal products approved via MRP/DCP
As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.