Read your device profile and answer focused questions
Complya prepares the profile from your sources; your expert reviews it and asks for the information still needed.
Where to find it
My Cases → Your case → Device information
You need
- Basic device information and supporting source documents.
Supply your device information and documents. Complya prepares a readable profile with source references and uncertainties. Your expert checks supported information, corrects mistakes and releases focused questions when clarification is needed.
What you see
| On the page | What it means |
|---|---|
| Device profile | Prepared values, their sources and the review state. You can read the profile without confirming every value. |
| Needs your answer | Questions your expert has released to you. Each shows what is needed, what was found and why clarification is necessary. |
| Response saved — waiting for expert review | Your reply is recorded. Your expert still needs to review it. |
| Reviewed | The expert has reviewed the request's response. The recorded history identifies the actor and act. |
Answer a released request
- Read the question, source context and reason for clarification.
- Use the response or declaration control on that request.
- Choose Save response and check the saved state.
- Your expert reviews the reply and may release a follow-up if more information is needed.
You do not need to confirm every extracted fact or lock a fact set. Your expert finalises the factual basis. A manufacturer declaration is requested explicitly and remains recorded as your declaration; an expert's review is recorded separately.
Device information is the working profile. The generated Device Description and Specification is a separate document under Documents.
What happens next
- Your expert reviews supported values and your replies, resolves outstanding issues and finalises the profile.
- Classification and document review continue through their own recorded expert decisions.
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