Clinical evaluation of medical devices

Clinical evaluation brings together the evidence for a medical device’s safety, performance and benefit–risk profile throughout its life. The parts divide by the work involved: establishing the process and evidence, planning and reporting the evaluation, describing devices and the state of the art, reviewing literature and registries, qualifying the team, preparing for assessment and producing the public summary. A further part covers MEDDEV 2.7/1 revision 4’s changes to that work. Device regulation and market access, clinical investigations, and post-market surveillance belong to neighbouring concerns.

• What clinical evaluation is, and why it never finishes — the process, its plan and report, evidence across the device lifecycle, and feedback from post-market reports
• Which clinical evidence counts — sources and rankings of evidence and the level needed for a device
• Writing the clinical evaluation plan — required contents, guidance, the clinical development plan, contributors, readers and updates
• Structuring and drafting the clinical evaluation report — guidance, inputs and responsibilities, the contents list, summary and scope
• Describing the device and any equivalent you rely on — describing the device and establishing clinical, technical and biological equivalence
• Identifying and using similar devices — distinguishing similarity from equivalence, selecting similar devices and using their data in clinical documents
• Building the state of the art — establishing medically accepted practice through a separate search, appraisal and account that the public summary can reuse
• Planning and running the literature search — review questions, protocol, strategy, databases and registers, reproducibility and updates
• Appraising and analysing the literature — relevance, weighting, exclusions, data extraction and analysis across the evidence
• Implant registries as clinical evidence for devices — finding registries, judging their suitability, analysing their data and recognising their limits
• Qualifying the evaluation team and signing the report — collective qualifications and the writer’s name, CV, declaration of interest and signature
• What the notified body assesses — the body’s focus, scrutiny and reading of interlinked documents, and preparing the report for assessment
• The Summary of Safety and Clinical Performance — applicable devices, professional and patient sections, inputs, readability testing, review, translation, publication and updates
• How revision 4 of the guidance changed the work — the guidance’s standing, changes to evaluation and reporting, implementation and its relationship to the Medical Device Regulation