3 Things Many Manufacturers Don’t Realize Yet
25 July 2026
Three things many manufacturers don’t realize yet about EUDAMED:
1. Registration isn’t a one-time task.
New products, EMDN code updates, certificate changes — all require ongoing data maintenance, not a single upload.
2. More modules are coming.
Vigilance & Post-Market Surveillance and Clinical Investigations aren’t mandatory yet — but they’re coming. Whoever sets up the right process now won’t be starting from zero later.
3. Bulk-upload XML doesn’t forgive small mistakes.
One wrong field can reject an entire batch. Validation before conversion isn’t a nice-to-have — it’s what saves you days.
If you’re managing EUDAMED registrations — whether in-house or through a consultant — happy to share what we’ve learned.