ARTICLE SUMMARY:
The European Union has laid out timelines for EUDAMED mandates. Excerpted from Pathways’ Picks July 17: Digital Therapeutics Payments, EUDAMED Timeline, and CDRH Reorganization.
The EU Medical Device Regulation has been in effect since 2021 but a core requirement of the regulation, for companies and others to disclose information to the new EUDAMED database, remains unfinished and subject only to voluntary submissions. The European Commission is now targeting 2026 for when the EUDAMED mandates will finally start to kick in. Under a schedule unveiled by the Commission last week, submissions to four (of a total of six) modules of EUDAMED will be mandatory starting in the first quarter of 2026 and one additional module will be added in the third quarter. Specifically, companies will be required to register themselves (in the “Actors” module), their devices, and market surveillance information, and notified bodies will be required to register and record device certificates they have issued in Q1 2026. Later that year, the Commission suggests, companies must start submitting adverse events to the “Vigilance” module of the database. This new schedule was made possible by recent legislative reforms allowing the EU to initiate EUDAMED reporting mandates for each module individually after they are available and fully validated, rather than having to wait until the entire database is ready. The Actors, devices/UDI, and notified body/certificates modules have already been up and running on a voluntary basis for several years, while the surveillance and vigilance modules are not yet in use. The Commission doesn’t include a mandatory date for the final, most-delayed module, for registering clinical investigation and performance studies.