How to get an SRN in Poland: EUDAMED + URPL in practice

Step order, common application gaps, and what Submitted → Registered actually means.

Informational material, not legal advice. SRN decisions belong to the competent authority (in PL: URPL) — we do not guarantee timeline or outcome.

In PL practice, what burns time is rarely the Submit click itself — it is the rework after a mismatch: Actor name or address that does not match the company registry down to the comma.

A sequence that usually works

  1. Set up / recover EU Login and appoint LAA
  2. Collect Actor data and compare them with registry documents
  3. Fill and consistency-check fields before submit
  4. Submit in EUDAMED → wait for CA
  5. After Registered / SRN issued — then device UDI batches

Common gaps that stall applications

Statuses: Submitted → Registered

Submitted means data entered the workflow — not that SRN already exists. Registered (or the equivalent final module status) is when you can use the SRN in later steps. Time between statuses depends on the CA, not on an advisory studio.

Fixed-price support: EUDAMED Express (checklist + mapping + expert review).

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© 2026 AZ Regulatory · Alicja Załanowska. Informational material — not a notified body or authority.