Clinical Evidence for SaMD in the EU
MDR Requirements
SaMD must show:
- Clinical association (medical logic)
- Analytical validity (correct processing)
- Clinical validation (real-world benefit)
Documentation:
- Clinical Evaluation Plan (CEP) = how you’ll gather evidence
- Clinical Evaluation Report (CER) = full evaluation
- Post-Market Clinical Follow-up (PMCF) = follow-up after launch
Use real-world evidence, literature, or clinical studies.
This post is part of SaMD Europe Launch Guide.
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