EUDAMED mandatory — what to change in the company (RA checklist)

I most often see the same start mistake: the company begins with a device list, but has no clear LAA and Actor data that match the company registry. UDI then waits anyway.

1. Split two tracks: Actor and UDI

Actor registration (SRN) uses different forms and data — and often a different submitter — than device registration (UDI). Map economic operator roles first, then the device list.

2. Name the Local Actor Administrator (LAA)

Without a clear LAA and EU Login, EUDAMED stalls. Plan holiday cover and where credentials live — not on WhatsApp.

3. Weekly QA/RA checklist

• Week 1: EO role list + process owner
• Week 2: Actor data pack (name, address, contacts, entity identity documents)
• Week 3: device / Basic UDI-DI list for the first batch
• Week 4: IFU / label / file consistency with UDI fields
• Next: Actor submit → wait for SRN → UDI in batches

4. What not to do

• Promise yourselves “SRN in 48 hours” — timing depends on the competent authority
• Treat EUDAMED as a PRRC or CE substitute
• Send full UDI / DoC via messengers

Ready-made checklist support: EUDAMED Express.