A clinical evaluation plan is a strategic plan that defines the clinical evaluation process required by MEDDEV 2.7/1 rev 4 and EU MDR article 61 and Annex XIV Part A. The clinical evaluation plan acts as planning document for your clinical evaluation and all the activities of Clinical Evaluation are carried out as per the Clinical Evaluation Plan.
Both MEDDEV 2.7/1 rev 4 and MDR 2017/745 Annex XIV part A provides more details on the requirement of the clinical evaluation plan
a) Before and after CE marking
b) After CE marking
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