TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT SUMMARY REPORT ON A MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
ANNEX VSupplementary provisions
ANNEX V TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT SUMMARY REPORT ON A MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE The summary report shall be concise and an independently readable overview of the assessment. The summary report shall include, at least the following information: (a) a description of the intervention, medical condition and/or target population; (b) the assessment scope provided for in Article 8(6) of Regulation (EU) 2021/2282; (c) information on the involvement of patients, clinical experts and other relevant experts, as well as on the input received from patient organisations, healthcare professional organisations and clinical and learned societies; (d) summary tables including uncertainties of the evidence for each set of parameters for the joint clinical assessment in terms of patient population, intervention, comparators and outcomes, with short description of the results.