Complete the regulatory profile
Record the quality system certificate and your declarations — the PRRC route, the ISO 13485 position — and follow their review states.
Where to find it
Quality system → Regulatory profileYou need
- The organisation's PRRC information and ISO 13485 position; the certificate details if one exists.
The Regulatory profile tab has two sections. Quality system certificate records the certificate on file — its route, number, notified body and dates — or that the notified body will assess the quality system. Your declarations records the PRRC route (degree, experience or custom-made devices) with the conditional details that follow from the route, and the ISO 13485 position (certified, certification in progress, ISO 9001 only, MDSAP, or no external certificate).
Save truthful declarations; do not fill a certificate number or a route merely to clear a row. A row with no value stays open until a value is saved, and a required row says so and points at Edit details.
A declaration your expert returned carries "Sent back" and the expert's note under the row; save a corrected value to send it again. One you changed after approval reads "With your expert" until they look at it again.
What the states mean
| State | Meaning |
|---|---|
| Not provided yet | A required value has not been saved; the row reads "Not provided yet · use Edit details" and carries no chip. |
| With your expert | The saved value is in the expert's queue. |
| Approved | The expert confirmed the current declared value. |
| Sent back | The expert returned the declaration; the note under the row says what must change. |
| Needs resubmission | A governing fact changed, so the retained value must be saved again. |
| Optional · not provided | The optional field has no value and nothing is owed. |
What happens next
- Correct returned declarations, or wait for your expert's review of saved ones.
Related guidance
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