There have been around 222k processed registrations into EUDAMED over the last 600 days according to some of the internal analytics at our company ( https://orca1.ai/ )!
EUDAMED (European Database on Medical Devices) is an IT system created by the European Commission under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). Its primary function is to improve transparency and strengthen the oversight of medical devices that are placed on the European market. The system is not yet fully operational, but is expected to be up and running towards the end of this year.
I am curious how much information this system will store and how it will be used by regulatory bodies, whether it be for audits/inspections or market surveillance. Please share if you know any more information on this.
