FRAMEWORK FOR THE CLINICAL EVALUATION OF MEDICAL DEVICES

FROM CLINICAL CLAIMS TO A LIFECYCLE EVIDENCE STRATEGY

What does a robust clinical evaluation really require under the EU MDR?

This presentation introduces a practical nine-step framework for clinical evaluation, beginning with the intended purpose and clinical claims and continuing through evidence identification, evidence strategy, systematic literature searching, critical evidence assessment, clinical conclusions, PMS, PMCF and lifecycle maintenance.

It explains why the volume of clinical data alone does not determine the quality of a clinical evaluation, how different evidence sources should be systematically assessed and integrated, and why the quality, relevance and transferability of available evidence need to be critically evaluated.

The presentation also shows how the nine-step approach connects clinical evaluation with risk management, PMS, PMCF and technical documentation, helping manufacturers identify evidence gaps and maintain a consistent, scientifically justified clinical evidence base throughout the product lifecycle.

KEY TOPICS

• Clinical evaluation requirements under the EU MDR

• Intended purpose and clinical claims as the foundation of clinical evaluation

• Alignment of clinical evaluation with risk management

• Identification and systematic integration of available evidence sources

• Development of a documented and reproducible evidence strategy

• Systematic identification and evaluation of relevant scientific literature

• Assessment of evidence quality, relevance and transferability

• Evidence-based conclusions on safety, performance and benefit-risk

• Integration of PMS and PMCF into the clinical evaluation

• Identification and management of clinical evidence gaps

• Consistency between the CER and technical documentation

• Lifecycle maintenance and defined triggers for updating the clinical evaluation