Understand evidence archetypes
Use plain-language source categories as a proposed relationship, not as acceptance.
Quality system
Where to find it
Quality system → Quality evidenceYou need
- A source document to classify for evidence review.
An archetype says what kind of evidence a controlled source appears to be, such as a quality manual, risk-management procedure, clinical report or audit procedure. It helps route the source to relevant obligations.
What happens next
- Review the resulting coverage rows and address any returned or untagged-document request.
Related guidance
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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