For manufacturers, authorised representatives, and distributors of medical devices and IVDs in the EU, the May deadline represents the moment when full EUDAMED requirements take effect across all relevant modules. With just 60 days remaining, the time for gradual preparation has effectively passed.
This article outlines the key actions still required, highlights where organisations most often fall short, and provides guidance on navigating the final stretch before the EUDAMED deadline without making costly mistakes.
