The Medical Devices Introductory Course 2020

Who should perform the clinical evaluation? (2)

Evaluators should possess knowledge of the following: • Research methodology (including clinical investigation design and biostatistics) • Information management (e.g. scientific background or librarianship qualification; experience with relevant databases e.g. Embase) • Regulatory requirements • Medical writing • The device technology and its application; • Diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (i.e. specialist clinical expertise in the relevant medical specialty )

The Organisation for Professionals in Regulatory Affairs

A note on the importance of team work

Finding one person with the time, experience, expertise and knowledge to fulfil every aspect of what the evaluator is required to do is possible but highly unlikely in most circumstances A team-based approach to clinical evaluation is recommended • The most appropriate team to perform the clinical evaluation should be considered by the manufacturer as early as possible • Not everyone involved has to be an evaluator but experts should be consulted and, in some circumstances, it may be appropriate for them to be an evaluator • There is no reason why manufacturers cannot standardise who performs the clinical evaluation for their products, providing this approach can be adapted when required

The Organisation for Professionals in Regulatory Affairs