Six industry associations on medical devices and healthcare have jointly signed an open letter on the mandatory use of EUDAMED. The six associations call for important prerequisites necessary before any modules of EUDAMED would be made mandatory, as demanded by some EU Member States at the last EPSCO meeting in November.
Essentially, the letter highlights four preconditions:
1. The modules are fully developed, tested, audited, and ready for practical implementation
Users must test all mandatory EUDAMED modules. Any elements or modules which will become mandatory at a later stage should be integrated and usable with the other modules, without causing any additional work on the modules that are already populated with data.
2. EUDAMED enables the most efficient use of Notified Body and Manufacturer resources
The first EUDAMED mandatory version must include a Machine-to-Machine communication functionality for the module dedicated to notified bodies and certificates. Moreover, the functionality to upload the non-validated and translated versions of Summary of Safety and (Clinical) Performance reports should be transferred from the notified bodies to the manufacturers. In this way, manufacturers can edit the data to maintain data accuracy.
3. Realistic and reliable implementation and transition timelines are provided
Companies and compliance partners such as notified bodies should be provided with a reasonable implementation timeline. This is essential to align their procedures and build up their resources, tools, and infrastructure for EUDAMED. In addition, the joint letter suggests that all EUDAMED users should have the final documentation and a lead time of at least 24 months before the mandatory use of any modules.
4. Redundancy in National Databases is eliminated
The introduction of EUDAMED should remove the obligations for actors and devices to register in national databases. If some national databases for distributors’ registration will still exist, they should align with EUDAMED to leverage data attributes on devices from this central and single source.