This working group will assist and advise the MDCG on policy and technical matters related to the establishment, management and maintenance of the European Database on Medical Devices (EUDAMED), including the implementation and application of the relevant provisions of the MDR and IVDR. In doing so, the Subgroup will support the development process of the necessary specifications and technical functionalities related to EUDAMED.
In particular, the working group
- will collaborate with other MDCG sub-groups on relevant EUDAMED modules (e.g. MDCG unique device identification (UDI), MDCG post-market surveillance and vigilance (PMSV), MDCG clinical investigation and evaluation (CIE), and MDCG market surveillance
- will provide horizontal support and coordination as well as prepare directions on future work items in line with regulatory requirements
- will prepare draft guidance for endorsement by MDCG in its activity field if necessary
- will advise the Commission during the early preparation of implementing acts foreseen in the MDR and IVDR
The submission deadline for this call is 15 June 2020.