Work Package 1 will review and summarise the designs of studies that have generated clinical evidence about the performance high-risk medical devices. Specifically, it will collect evidence concerning high-risk (class III) permanently implanted devices in the fields of cardiology and orthopaedics, as well as high-risk devices used for the treatment of diabetes mellitus.

Objectives

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To perform a systematic review of recommendations for the performance of clinical investigations and trials of high-risk medical devices, identifying their concordance and discordance

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To perform a systematic review of the methodologies of clinical investigations that have been used to evaluate high-risk cardiovascular, orthopaedic and diabetic medical devices, identifying problems and ranking study designs for their quality and appropriateness.

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To review appropriate statistical methods for evaluating studies of high-risk medical devices

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To review the utility of patient-reported outcome measures and patient-reported experience measures to generate premarket and post-market clinical evidence for high-risk devices, including independent review of their validity and accuracy