Complete the regulatory profile
Record PRRC and ISO 13485 declarations and follow their review states.
Quality system
Where to find it
Quality system → Regulatory profileYou need
- The organisation's PRRC information and ISO 13485 position.
The regulatory profile asks for PRRC and ISO 13485 facts, including conditional details that appear from the governing answers. Save truthful declarations; do not fill a certificate number or route merely to clear a badge.
One further chip can appear beyond the six statuses: "Changed — re-approval pending", when you altered an approved value. A returned declaration also carries a note box headed "Sent back by your expert"; a declaration that must be proposed again and has a note is headed "Please re-submit".
What the states mean
| State | Meaning |
|---|---|
| Needs you | A required declaration has not been submitted. |
| Awaiting expert | The current proposal is in the expert queue. |
| Confirmed | The expert confirmed the current declared value. |
| Needs resubmission | A governing change means the retained value must be proposed again. |
| Sent back | The expert returned the declaration; the note explains what must change. |
| Optional | The optional field has no value and nothing is owed. |
What happens next
- Correct returned facts or wait for expert review of submitted values.
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Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.
European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices