EUDAMED mandatory — what to change in the company (RA checklist)
A practical order of work for QA/RA: appointing the LAA, preparing company data (Actor) and registering devices (UDI).
I most often see the same initial 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
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