Regulation (EU) 2017/745 of the European Parliament and of the CouncilShow full title

1. To plan, continuously conduct and document a clinical evaluation, manufacturers shall: U.K.

(a)

establish and update a clinical evaluation plan, which shall include at least:

• an identification of the general safety and performance requirements that require support from relevant clinical data;

• a specification of the intended purpose of the device;

• a clear specification of intended target groups with clear indications and contra-indications;

• a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;

• 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;

• 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;

• 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

• 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;

(b)

identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review;

(c)

appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device;

(d)

generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues; and

(e)

analyse all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.