The Medical Devices Introductory Course 2020

When is clinical evaluation performed? (2)

Must be actively updated thereafter throughout the lifecycle of the medical device • When the manufacturer receives new information from PMS that has the potential to change the current evaluation OR if no such information is received: • yearly if the device carries significant risks or is not yet well established or • every 2–5 years if the device is not expected to carry significant risks and is well established (a justification should be provided)

The Organisation for Professionals in Regulatory Affairs

Who should perform the clinical evaluation? (1)

”The clinical evaluation should be conducted by a suitably qualified individual or a team ” • The manufacturer defines requirements for the evaluators that are in line with the nature of the device under evaluation and its clinical performance and risks • The manufacturer should be able to justify the choice of the evaluators through reference to their qualifications and documented experience, and to present a declaration of interest for each evaluator

The Organisation for Professionals in Regulatory Affairs