The Medical Devices Introductory Course 2020

Clinical evidence

Available from: https://www.bsigroup.com/meddev/LocalFiles/enUS/Roadshow %20Resources%202016%20Fall/MDR%20Clinical%20Requirements.pdf

The Organisation for Professionals in Regulatory Affairs

Clinical Evaluation Process involves:

• Establishing scope and identifying relevant GSPRs • Examining claims made about the device • Identifying equivalent devices on the market • Carrying out and documenting a comprehensive literature search • Collating clinical data from various sources such as clinical investigations, internal complaint files, external vigilance • Appraising and analysing the clinical data • Determining whether there is a need for additional clinical data to be generated • Determining whether there is a need for Post Market Clinical Follow-up (PMCF) studies

The Organisation for Professionals in Regulatory Affairs