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Writing Clinical Evaluation Reports

Level:
Advanced
Area:
Medical Devices
Code:
MDA2
Duration:
03:30:00
Workshop profile:
Medical writers with experience in regulatory writing for medicinal products or medical devices. Participants should have attended the workshop ‘Introduction to Writing for Medical Devices’ or should have a basic knowledge of the market approval process for medical devices.
Objective:
To provide guidance and insight into the clinical evaluation process and report writing for medium- and high-risk medical devices.
Content:
Main elements of the workshop are: • A brief overview of the market approval process and the role of the clinical evaluation • The Clinical Evaluation Plan • The Clinical Evaluation Report (CER): content and data/documents to be used for its preparation o Pre-clinical and clinical data o Risk management documents o Post-market surveillance documents o Claims o Device information provided by the manufacturer to the user o State-of–the-Art analysis o Benefit/risk assessment The workshop will include group exercises and discussions as well as evaluations of anonymised documents.