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.
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- 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?
MDR, Annex XIV, Part A, Clinical evaluation mandates the inclusion of Clinical Evaluation Plan (CEP) which also comprises the general safety and performance requirements (GSPR) with support from relevant clinical data.
• Risk Management
• Foreseeable hazards
• Clinical performance
• Clinical safety
• Intended use
• Foreseeable misuse
• Production phase information
Yes, CEP should consider the specified and relevant clinical outcome parameters with detailed description of intended clinical benefits to patients.
Clinical benefits varies as per the nature of medical devices, its class and intended purpose. Clinical benefits information can be retrieved from manufacturer, clinical data and PMS.