To develop the scope of the clinical evaluation to be conducted on the medical device, as well as to plan a sound method for identifying, collecting, and analyzing clinical data with the proper schedule and clinical evaluation team.
Clinical Evaluation Plan MDR
The medical devices that require demonstrating the safety and performance with the help of clinical data
The clinical evaluation should begin with a well-organized clinical evaluation plan. The following details must be included.
Plan of Clinical Evaluation
The Clinical Evaluation Plan should be established and updated based on the aspects as listed below:
- Information of start date, expected completion date and that of the responsible personnel involved in the clinical evaluation
- 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 state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and the intended purpose or purposes of the device;
- an indication of how benefit-risk issues relating to specific components such as the use of pharmaceutical, non-viable animal or human tissues, are to be addressed; and
- a clinical development plan should indicate 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 with an indication of milestones and a description of potential acceptance criteria.
- A list of responsible personnel for the different Clinical evaluation activities with a planned schedule must be created.
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