The evidence sources
The evidence sources: the four accepted data sources and the systematic literature search your NB audits.
Free field guide · PDF
EU MDR Clinical Evaluation2026 Field Guide
The evidence sources, the equivalence test, and the CER practice — with the clinical-evidence work you need.
- Data sources
- 4
- Equivalence
- 3-axis
- CER rule
- Art. 61
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The equivalence test
The equivalence test: technical, biological, clinical similarity — the strictest gate in the file.
The CER practice
The CER practice: MEDDEV 2.7/1 Rev 4 structure, per-class update cadence, and the PMCF evidence loop.
Sources & scope
- greenlight.guru, What EU MDR clinical evaluation requires.
- greenlight.guru, Clinical Evaluation Report (CER) for Medical Devices: EU MDR.
- medium.com, How to Write a Clinical Evaluation Plan and Report for EU MDR Compliance (Feb 2026).
This guide is market-access intelligence, not regulatory or clinical advice. MDR clinical evaluation requirements, MEDDEV/MDCG guidance, and notified-body practice change — professional review is required before business use.
Market Access Strategy Session
CER on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your clinical evidence route — literature strategy, equivalence planning, and PMCF design.
Professional review is required before business use.
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