What's Coming in 2027
15 August 2026
EUDAMED isn’t finished rolling out. Two more modules are still ahead: Vigilance & Post-Market Surveillance, and Clinical Investigations — both still pending activation, expected sometime in 2027.
Here’s the part worth planning for: when a module goes live, there’s no soft opt-in period beforehand. It becomes mandatory on a set date, the same way the first four modules did in May 2026.
That means the manufacturers who get ahead of it now — clean product data, a working registration process, a system instead of a folder of spreadsheets — won’t be scrambling when the deadline lands. The ones who wait will be doing exactly what’s happening right now with the legacy device deadline: compressed timelines, rushed data entry, avoidable mistakes.
Registration workflows you build today for MDR and legacy devices are the same foundation you’ll need for what’s coming. It’s not wasted effort — it’s early effort.