Eudamed Registration Module to Launch in December

The European Commission’s Medical Device Coordination Group has announced that a new Eudamed registration module will go into effect on Dec. 1, enabling users to create a unique registration number to access the safety database.

The new registration numbers will identify manufacturers, authorized representatives and importers in the database, which will be used to monitor the safety and performance of devices and in vitro diagnostics under the EU’s new regulations.

The registration module “forms a prerequisite for the use of the other Eudamed modules and facilitates a secure way of accessing Eudamed,” the device group said.