...But this database (EUDAMED) will not be publicly accessible. Instead, only the EU national regulators will have access.
A databank with ‘everything’ for ‘everyone’…
The MDR Eudamed will not only be used by the National Competent Authorities (NCAs) and the European Commission. It will also be accessed by:
Medical Devices Coordination Group (MDCG);
Notified Bodies (NBs);
Economic Operators (EOs - manufacturers, authorised representatives, importers, sponsors);
Non-European Competent Authorities;
And the public, including medical institutions and the press.
Depending on the type of user, only certain levels of the databank can be accessed. The end result should be that there is more transparency in what medical devices are distributed where and who is responsible for them.