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Clinical Evaluation Overview

Overview​

A clinical evaluation is the systematic, planned, and continuously updated process of generating, collecting, analysing, and assessing clinical data to verify safety and performance for the intended use. Required for all medical devices under MedDO Annex XIV and is a mandatory component of technical documentation. The requirements are identical to EU MDR Annex XIV.

Sources of Clinical Data​

  1. Clinical investigations of the specific device (see Clinical Investigations)
  2. Literature data for an equivalent device — requires rigorous equivalence demonstration (technical, biological, and clinical characteristics)
  3. Post-market data — PMCF, complaint data, literature, and registries (used to update the CER post-market)

Clinical Evaluation Report (CER) Structure​

A well-structured CER typically includes:

  • Scope definition (intended purpose, indications, patient population, intended user)
  • Identification and appraisal of relevant clinical data
  • Analysis of clinical data — safety outcomes, performance/efficacy outcomes
  • Conclusion — demonstration that GSPRs are met, risks are acceptable given benefits
  • List of references and data sources

Equivalence​

Using clinical data from an equivalent device requires documented demonstration of equivalence in all three dimensions: technical (same design, materials, specifications), biological (same tissues, body fluids, contact duration), and clinical (same intended use, patient population, clinical condition). The threshold for claiming equivalence under MedDO is high — MDCG 2020-5 applies.

PMCF​

The clinical evaluation must be updated throughout the device lifecycle based on PMCF data. The PMCF plan and report form part of Annex III post-market documentation.

Official Sources​

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.