Clinical Evaluation Plan (CEP)

The Clinical Evaluation Plan (CEP) is established and updated in support of a clinical evaluation of a medical device, which is a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to the device. The CEP should identify the general safety and performance requirements that require support from relevant clinical data and should include a clinical development plan as well as a post-market clinical follow-up with an indication of milestones and a description of potential acceptance criteria. Requirements for the CEP are detailed in Annex XIV (Part A, Section 1) of the Medical Devices Regulation (2017/745).

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