EUDAMED is the European Databank on Medical Devices which came into force in May 2011. EUDAMED was created as a central repository for information on market surveillance exchanged between national competent authorities and the European Commission, with the purpose of strengthening surveillance and transparency with regards to medical devices placed on the European market.
The new regulations on medical devices (MDR) and on in vitro diagnostic medical devices (IVDR) establish a much wider EUDAMED database than the existing one under the current European Directives.
Updates continue to be issued from the European Commission concerning EUDAMED in light of the current COVID-19 pandemic.
The EUDAMED launch has been postponed with a two-year delay compared to initial expectation, until May 2022. However, the European Commission has announced that some modules of EUDAMED will be made available to users before the official EUDAMED date of application in May 2022. Hence, it becomes possible for economic operators to start using EUDAMED before May 2022.
At present, the European Commission has the following implementation plan:
2021 March: the Actor Registration Module will become available. This module will allow for manufacturers, authorized representatives, importers as well as systems and procedure pack producers to enter their data in EUDAMED and to acquire a Single Registration Number (SRN) for declarations of conformity and certificates.
2021 May (expected): the UDI/Device Registration Module and the Certificates and Notified Bodies Modules will be made available (after the Actor module, as soon as functional). At this time, it is anticipated that manufacturers will be able to begin submitting UDI information to EUDAMED.
2022 May: EUDAMED Launch (all modules complete and released, e.g., clinical investigations, incident reporting and market surveillance will become available afterwards as soon as they are functional).
2022 May – 2023 Nov: EUDAMED Device Registration period of 18 months for Legacy, MDR, and IVDR devices.
References:
1. European Commission – European database on medical devices (EUDAMED) – https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en
