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CATEGORY: DOCUMENTATION
Declaration of Conformity (DoC)
A document in which the manufacturer formally declares that a medical device meets all applicable regulatory requirements. Under EU MDR, the DoC must reference the regulation, Notified Body certificates, and applicable harmonized standards.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
The EU Declaration of Conformity is the manufacturer’s formal statement that a device meets MDR/IVDR requirements before CE marking and placing on the market.
PROCESS / STEPS
- Complete conformity assessment route.
- Identify applicable legislation and standards.
- Sign DoC with manufacturer identity and device identifiers.
- Keep DoC updated with certificate scope changes.
EXAMPLES
- Distributors and importers often request the DoC as part of due diligence.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Declaration of Conformity (DoC) across 27 authorities in real time.
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