MEDDEV 2.7/1 Revision 4 Clinical Evaluation Plan

It is one of the requirement of MDR to have a “CLINICAL DEVELOPMENT PLAN” as part of “Clinical Evaluation”.

A clinical development plan is a blueprint of entire process of medical device lifecycle from planning to post launch stage including Designing Stage, Prototype Development, Testing Stage, Preclinical Investigations, First in Human Studies, Feasibility Pilot Studies, Pivotal Studies and a PMCF with an indication of milestones and a description of endpoints included

Clinical evaluation plan contains a sound method for identification, collection and analysis of the clinical data with the proper time schedule and clinical evaluation team. Also, the scope of the clinical evaluation to be conducted on medical device.

  • an identification of the general safety and performance requirements that require support from relevant clinical data?
  • Is there a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters should be considered in CEP?