Module 14 2022

22/03/2022

• Review of clinical investigations • investigations reported in the literature on a device for which equivalence to the device can be demonstrated • Other supporting information (e.g. peer-reviewed scientific literature) • Other relevant information • such as data from a manufacturer’s post-market surveillance/clinical follow up Of sufficient quantity and quality to enable a qualified assessment of safety and achievement of intended clinical benefit Demonstrate a methodical and systematic evaluation of collecting, analysing and assessing clinical data, and continuing monitoring. CLINICAL EVALUATION REPORT

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

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CLINICAL EVALUATION REPORT

• Device Name and UDI • Description, inc. previous versions, differences, accessories and products intended to be used in combination with the device • Intended purpose, including the indication, contraindications and target population • Note any diagnostic or therapeutic alternatives that are available • Reference any harmonized standards or common specifications applied • Relevant information on post-market clinical follow-up • Any requirements or training needs for users • Information on any warnings or precautions for use, undesirable effects, or other risks.

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

28

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