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CATEGORY: REGULATORY PATHWAYS
Conformity Assessment
The process by which a manufacturer demonstrates that a medical device meets the applicable regulatory requirements. In the EU, conformity assessment involves Notified Body review for Class IIa and above, culminating in a CE certificate.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Conformity assessment is how manufacturers demonstrate devices meet applicable rules—self-declaration for some low-risk devices, third-party NB assessment for higher risk in the EU, and analogous FDA premarket paths in the US.
PROCESS / STEPS
- Determine device class and legal route.
- Compile evidence and QMS proof.
- Engage NB/FDA/authority as required.
- Issue DoC / obtain clearance/approval/certificate.
EXAMPLES
- EU Class III implants use the most demanding NB conformity assessment routes.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Conformity Assessment across 27 authorities in real time.
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