Review extracted device facts and lock the fact set
Use the action shown for each fact, then lock the set so your expert can sign off.
Where to find it
My Cases → Your case → Device classification
You need
- A case whose source material has produced facts for review.
Each fact card shows what it needs from you as a chip — "Confirm", "Choose the right reading" or "Only you can answer" — and offers the matching buttons: "Looks right", "No — it's <the other value>", or "Pick a different answer". The rail on the left tells you what is still yours to do; the page's own "What needs you" section is the list it points at.
What you see
| On the page | What it means |
|---|---|
| What needs you | A section heading in the page body — the list of facts and answers still waiting on you; the rail's checklist jumps to it. |
| Ready to lock | Everything you can settle is settled — the lock button is live. |
| Provisional | The class the current facts produce; it is not released. |
| Locked & sent | You locked the set; it is with your expert for review and sign-off. |
| With your expert | Shown in the rail once you have locked; your facts are read-only while your expert certifies the class. The rail reads "Locked and with your expert for review and sign-off." and "Awaiting expert sign-off." |
| Released · certified | Your expert reviewed and released the classification. |
Review each fact
- Read the fact and its source context.
- Use the action shown on that row.
- Enter a correction or answer in the field provided, then submit it.
- Continue until "What needs you" is empty.
Lock the fact set
Locking is your act, and your expert cannot sign off until you do it. The rail reads "Everything you can settle is settled — ready to lock." when the button is available; until then it says "Clear the steps above to lock." and lists what is missing.
- Clear everything under "What needs you".
- Review the device details the rail points at.
- Until you lock, you can still change any answer. Once you choose "Lock fact set" the set is read-only and with your expert for certification.
- Read the confirmation: "Locked and with your expert for review and sign-off."
What happens next
- A locked fact set is what your expert signs off; the class stays Provisional until you lock and they sign.
- Expert-owned judgements still wait for the expert — a banner above the fact list says "Your expert handles this step in parallel — please still complete the remaining items below."
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