Clinical Evaluation Templates

These clinical evaluation templates help organise the MDR process from planning through the final clinical evaluation report and its ongoing updates. The collection includes tools for defining clinical claims and benefits, identifying relevant safety and performance requirements, searching and appraising clinical data, analysing equivalence, documenting conclusions, and checking report completeness.

Begin with a device-specific clinical evaluation plan. Define the intended purpose, populations, claims, measurable clinical benefits, state-of-the-art benchmarks, relevant GSPRs, evidence sources, appraisal methods, and unresolved questions before searching the literature. Keep a reproducible search and selection trail, appraise methodological quality and relevance, and trace each conclusion to evidence. Feed remaining gaps into post-market clinical follow-up rather than hiding them in general wording.

The templates do not guarantee sufficient clinical evidence and do not replace the MDR, applicable MDCG guidance, or qualified clinical judgment. Adapt them to device class, novelty, risk, clinical history, and conformity-assessment route. Keep the report consistent with risk management, instructions for use, PMS, PMCF, SSCP, and technical documentation, and update it when new information changes—or could change—the benefit-risk conclusion.