What clinical evaluation entails for medical devices under the UK MDR 2002 — the clinical evaluation process, literature-based evidence, equivalent device approach, clinical investigations, and ongoing post-market clinical follow-up (PMCF).
How the clinical evaluation is presented and referenced in the medical device technical file under UK MDR 2002 — the Clinical Evaluation Report, its relationship to other technical file elements, and post-market update requirements.
How clinical data generated outside the UK — from EU, US, Japanese, Australian, Canadian, or other investigations and studies — can be used to support clinical evaluation under the UK MDR 2002.