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 Clinical evaluation checklist for Notified Bodies Ref Requirement Fulfilled Comment 0 Conformity without Clinical Data 0.1 Any demonstration of conformity without clinical data (Annex 7.1.5 of 90/385/EEC and Annex X.1.1d of 93/42/EEC) must be adequately justified and based on the output of the risk management process viewed in the context of the device-body interaction the intended clinical performance the claims of the manufacturer. Adequacy of demonstration of conformity based on performance evaluation, bench testing and pre-clinical evaluation in the absence of clinical evaluation must be duly substantiated. The notified body must review the manufacturer’s justification, the adequacy of data presented and whether or not conformity is demonstrated. Is the manufacturer’s justification adequate? Is the performance evaluation, bench testing and preclinical evaluation adequate to demonstrate conformity to the Essential Requirements? Yes No N/A  1 Clinical Evaluation, General 1.1 The manufacturer should include in the technical documentation a statement on the route(s) applied to retrieve the clinical data used to affix the “CE” marking. The statement should make clear whether that clinical data was obtained from the published literature or the results of clinical investigations or a combination of both and shall include an adequate justification of the route(s) selected and a demonstration of equivalency (technical, biological, clinical) and adequacy if clinical data from similar devices have been used. Yes No N/A Clinical literature Published Unpublished Equivalence demonstrated Clinical investigation Combination of literature and investigation data Comment 1.2 The Clinical Evaluation Report and the full clinical data used for CE marking should be included within the technical documentation Yes No N/A 1.3 The manufacturer has clearly documented the objectives and the scope of the clinical evalua