Several industrial associations, among which AESGP for the self-care industry and MedTech Europe for medical technologies, answered with a joint open letter to the call for early mandatory availability of the European Medical Devices Database (EUDAMED) made at the Employment, Social Policy, Health and Consumer Affairs Council meeting of 30 November 2023. The six associations highlight some preconditions which should be considered before any modules of EUDAMED would be made mandatory.
All the modules of the new database should be fully developed, tested, audited and ready for practical implementation, including the post-market surveillance and vigilance module and the public website. The database should enable the most efficient use of notified body and manufacturer resources. To this instance, the availability of a machine-to-machine communication functionality for the notified bodies and certificates module is expected, as well as the functionality for manufacturers to upload (non-validated and translated versions of) Summary of Safety and (Clinical) Performance reports.
The industry associations suggest a reasonable implementation timeline of at least 24 months from communication to starting mandatory use of any modules, in order to align procedures and build up resources, tools and infrastructure. Redundancy in national databases should be also eliminated.