November 26th, 2021, the European Commission issued the Implementing Regulation 2021/2078 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (EUDAMED).
This Implementing Regulation addresses the processes that actors must go through to obtain access to EUDAMED, explains that authorised users should use the free-of-charge European Medical Device Nomenclature (EMDN) codes when accessing the database, covers malfunctions, security risks and fraudulent activity, and details what help, and training will be available.
What does this mean to you?
This is an important Implementing Regulation relating to the functioning of EUDAMED.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.