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 to conduct a clinical investigation of a medical device in the UK — MHRA notification, ethics committee approval, protocol requirements, adverse event reporting, and post-investigation obligations under the UK MDR 2002.
Performance evaluation requirements for IVD medical devices under Part III of the UK MDR 2002 — analytical performance, clinical performance, scientific validity, and the Performance Evaluation Report (PER).
PMCF requirements for medical devices under the UK MDR 2002 — what PMCF is, when it is required, PMCF plan and report structure, methods, and how PMCF data feeds back into the clinical evaluation.
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.