Milestone reached: EUDAMED UDI & Devices registration and Notified Bodies & Certificates modules launched for voluntary use
Posted on 06.10.2021
On 4 October 2021, the European Commission announced the successful launch of the EUDAMED UDI & Devices registration and the Notified Bodies & Certificates modules (Production release of “v2.0 – September version”). This means that Economic Operators and Notified Bodies can start entering data on a voluntary basis into the European database on medical devices.
The official announcement of the fully functional EUDAMED is expected once the database is completed with all remaining modules (Clinical Investigation/Performance Studies, Vigilance and Post-Market Surveillance and Market Surveillance). This is foreseen for mid-2023 – see European Commission rolling implementation plan.
MedTech Europe kindly reminds all medical device and diagnostic companies that ultimately each manufacturer should decide whether or not to use EUDAMED under the voluntary regime (unless it is mandatory by national law).
The public will already be able to see some medical device and certificate registrations at the EUDAMED public site.