The Medical Devices Introductory Course 2020

Different stages of a clinical evaluation

GSPRs: General Safety and Performance Requirements

The Organisation for Professionals in Regulatory Affairs

When is clinical evaluation performed? (1)

Mandatory for initial CE-marking • Usually performed for the first time during medical device development to identify data that needs to be generated for market access • Premarket research and development should be guided by clinical evaluation and risk management • Mandatory for initial CE-marking and performed throughout the life cycle of a medical device as an ongoing process

The Organisation for Professionals in Regulatory Affairs