Essentials of European Medical Device Regulatory Affairs

Clinical Evaluation

CER needs to be updated based on • Information from PMCF • Post market surveillance plan

The PMCF evaluation report and summary of safety and clinical safety and clinical performance (article 32) for Class III and implantable devices needs to be updated annually.

The Organisationfor Professionals inRegulatory Affairs

Clinical Evaluation Report content

• Scope & Plan

• Devices Description • Clinical Evaluation Plan • Clinical literature review methods and documentation: • Specific safety and performance objectives • ERs considered to require clinical evaluation data (this should always include 1, 3, 6) • Links to risk management outputs • If applicable, demonstration of equivalence • Literature search strategy

The Organisationfor Professionals inRegulatory Affairs