![]() Generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues andĪnalyse all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.Ģ. Identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review Īppraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria ![]() an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non- viable animal or human tissues, are to be addressed and an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters a clear specification of intended target groups with clear indications and contra-indications a specification of the intended purpose of the device an identification of the general safety and performance requirements that require support from relevant clinical data ![]() To plan, continuously conduct and document a clinical evaluation, manufacturers shall: (a)Įstablish and update a clinical evaluation plan, which shall include at least: Clinical evaluation and post-market clinical follow-upġ. ![]()
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