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Clinical Evaluation Report

What a clinical evaluation report is​

A clinical evaluation report (CER) is a structured document that evaluates all available clinical data relevant to a device — from clinical trials, literature, and post-market experience — and concludes on the device's clinical safety and performance.

For Shonin applications, the CER (or equivalent clinical summary) is a required component of the application dossier. PMDA expects a systematic, evidence-based assessment rather than an unsupported narrative.

Alignment with IMDRF guidance​

Japan broadly follows the IMDRF guidance on clinical evaluation (IMDRF/MDCE WG/N56). PMDA expects the CER to:

  • Systematically identify all relevant clinical data (from clinical investigations, literature, and post-market sources)
  • Critically appraise the identified data
  • Conclude on whether the data demonstrates that the device meets its intended use safely and effectively
  • Identify any remaining uncertainties and how they will be addressed (post-market)

Structure of a clinical evaluation report for Japan​

A Japan-focussed CER typically includes:

  1. Device description and intended use — specific to the Japanese indication and labelling
  2. Clinical background — disease/condition overview, current treatment landscape in Japan
  3. Clinical data identification — systematic literature search (methodology documented) and list of clinical investigations
  4. Critical appraisal — evaluation of each data source's relevance, quality, and applicability to Japanese patients
  5. Clinical data synthesis — integrated analysis of safety and efficacy/performance
  6. Benefit-risk assessment — explicit benefit-risk analysis for the Japanese intended use
  7. Conclusion — statement of whether clinical evidence supports market access in Japan
  8. Post-market clinical follow-up plan — how residual uncertainties will be monitored

Literature review methodology​

PMDA expects a documented, reproducible literature search methodology — databases searched, search terms, inclusion/exclusion criteria, and data extraction process. This demonstrates that the literature review is systematic rather than selective.