Essentials of European Medical Device Regulatory Affairs

Clinical Evaluation Report content

• Clinical literature review methods and documentation: • Appraisal of clinical data from the literature • Other sources of data (registries, PMS, vigilance, comparison testing, unpublished data, …) • CER authors/evaluators qualifications (up to date CV and declaration of interest) • Bibliography • Frequency of updates • Conclusion • Clinical investigations and related documentation (if applicable)

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What do NBs assess ?

• State of the art/current knowledge established appropriately • Adequately documented the treatment options available • Adequately documented risks, benefits, adverse events, complications associated with their device type • Safety acceptable and consistent with objectives defined • Performance acceptable and consistent with manufacturer claims and objectives defined • Acceptable benefit/risk profile demonstrated • Clinical evaluation demonstrates compliance with relevant GSPRs

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