What is Clinical Evaluation

What is Clinical Evaluation

Understand the objectives, purpose and major components of medical device clinical evaluation under the EU MDR.

MDR CER Writing

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1. Introduction & basic concepts

  • Training course introduction
  • What is Clinical Evaluation
  • Clinical Evaluation in context
  • Basic principles of planning a CER
  • Five common pitfalls when writing a CER

2. Section-by-section guide

  • Overall CER stucture
  • Free CER Template
  • Section 3: Scope of the Clinical Evaluation
  • Classifying medical devices
  • Hypothesis & hypothesis testing
  • Section 4: Summary of CEP
  • General Safety & Performance Requirements (GSPRs)
  • Appraisal & weighting
  • Section 5: Harmonised standards
  • Section 6: Clinical background / SOTA
  • Principles of a Literature Review
  • Section 7: Equivalence
  • Equivalence - Further details
  • Section 8: Clinical evidence review
  • Overall summary of evidence
  • Section 9: Analysis
  • GSPR 1 analysis - Further details
  • Section 10: Benefit-risk analysis
  • Section 11: Conclusion
  • Remaining sections

3. CER templates

  • Choosing a CER template
  • EnableCE CER Template