Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation

The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders be it manufacturers notified bodies or competent authorities when they have to plan perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking.It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups spin-offs or other development projects or in counselling services. Dr. Tom Melvin Co-Chair Clinical Investigation and Evaluation Working Group