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.
- 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.
Please write to us with your questions. Remember to write the actual status of the CER with the device name and class.