Declare and control source documents
Classify manufacturer documents, record their status and preserve supersession history.
Technical file and documents
Where to find it
DocumentsYou need
- A manufacturer-controlled source document in the organisation library.
Declare and supersede — Documents
- Open the document's ⋯ menu on the Documents page and choose "Edit metadata" to declare its source kind; choose "I am not sure" instead of inferring a kind from its file name.
- Record the controlled identity and declared status the form asks for, and save.
- When a controlled successor replaces it, use the supersede flow in the same dialog so the relationship is recorded.
Retire and restore — Quality system › Quality evidence
Retiring is not on the Documents page. Open the document's card in Quality system › Quality evidence; the dialog is headed "Retire this document" (or "Restore this document") with a "Reason" field (placeholder "Why is this being retired?") — a reason is required before the "Retire document" button is live. A retired card stays visible, marked Retired, and can be restored the same way with a reason.
What the states mean
| State | Meaning |
|---|---|
| Risk Management File | The manufacturer's controlled risk-management record. |
| Manufacturer technical specification (Technical specification in the list) | A controlled technical specification. |
| Verification or test report (Verification / test report in the list) | Controlled verification, validation or test evidence. |
| Clinical evidence / clinical report (Clinical evidence in the list) | A controlled clinical source. |
| Labelling or IFU artwork/source (Labelling / IFU in the list) | Controlled labelling or instructions-for-use source. |
| Quality-system procedure or record (Quality-system record in the list) | A QMS procedure or record. |
| Completed quality-system record (filled in) (Completed QMS record in the list) | A record of something that actually happened — a closed CAPA, a completed review. Pick this when the form is filled in. |
| Blank quality-system form or template (Blank QMS template in the list) | An empty form or template. Pick this when the document shows the form rather than a completed instance of it. |
| Certificate (ISO, MDR or other) (Certificate in the list) | A certificate issued to you by a certification or notified body. We read its scope and compare it with your case. It does not by itself show that any individual procedure or record meets a requirement. |
| Other manufacturer-controlled document (Other controlled document in the list) | Another manufacturer-controlled source. |
| Manufacturer's own copy of a Complya-type document (Manufacturer legacy document in the list) | The manufacturer's own copy of a Complya-type document. |
| Software bill of materials (SBOM) (Software bill of materials in the list) | A controlled list of the software components your product is built from (a CycloneDX file), read by Complya. |
| Software release or build record (Software release record in the list) | A controlled record of a software release or build — version, build identity, configuration. |
| Security advisory or supplier anomaly list (Advisory or anomaly list in the list) | A file of security advisories (an OSV export) or your supplier's list of known problems (a CSV) that you checked your software against; Complya reads it and never fetches anything it links to. |
| Earlier biological evaluation plan (external) (Earlier biological evaluation plan (external) in the list) | A biological evaluation plan for your device written earlier by another evaluator. Complya reads it and compares it with your current plan; it does not approve what it concluded. |
| Earlier biological evaluation report (external) (Earlier biological evaluation report (external) in the list) | A biological evaluation report for your device written earlier by another evaluator. Complya records its conclusion as that evaluator's, never as Complya's. |
| Notified-body or publication record | A record from a notified body or a published source. |
| I am not sure (Type not set in the list) | The explicit choice when the source kind is not known. |
What the states mean
| State | Meaning |
|---|---|
| Draft | The controlled source is still a draft. |
| Approved | The source has been approved under the manufacturer's process. |
| Issued | The controlled source is issued for use. |
| Superseded | A later controlled source has replaced it. |
What happens next
- The current declaration can be selected as source evidence where the case offers it.
- A retired document stops standing as evidence; documents that cited it may show as needing review.
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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