EU Delays Implementation of Eudamed Until May 2022

The European Commission announced a delay in implementation of the European database on medical devices (Eudamed) until May 2022.

The EU’s Medical Device Regulation will go into effect as scheduled on May 2020, but Eudamed’s launch “ will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices,” the Commission said.

The Commission concluded that it will only be possible to make Eudamed operational once the system is fully functional and has been independently audited.