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Digital Health MedTech

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:

  1. Clinical Evaluation Plan (CEP) = how you’ll gather evidence
  2. Clinical Evaluation Report (CER) = full evaluation
  3. 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.

This content has been enhanced by GenAI tools.

By Piotr Wrzosinski

Piotr Wrzosinski is a Pharma and MedTech commercialization and digital marketing expert with 20+ years of experience across pharma (Roche, J&J), consulting (Accenture, IQVIA) and medical devices (BD).
He leads transformative EMEA Omnichannel Delivery Center team at Becton Dickinson and shares insights on Pharma, MedTech and Digital Health at disrupting.healthcare to speed up digital innovation in healthcare, because patients are waiting for it.

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