Clinical Evaluation Plan
To navigate EU MDR smoothly, the first and primary document to be prepared is a Clinical Evaluation Plan (CEP). A CEP is a tool that helps in
- Planning the activities
- Documenting the process and
- Continuously guiding clinical evaluation.
Chapter VI, Article 61 of the EU MDR details the relevant aspects to be considered for the critical evaluation of the clinical data that support the general safety and performance requirements (GSPRs).
Clause no. 1 has indicated the planning, conducting, and documenting of the clinical evaluation. Annex XIV, Part A explains the details explicitly to be covered in the CEP.
The Clinical Evaluations Plan also includes
- Statistical power
- Patient population
- Clear and measurable objectives
- Criteria for stopping the trial
- Ethical consideration and informed consent
Let us now understand about EU MDR Clinical Evaluation Plan Requirements & Contents:
- Identification of general safety and performance requirements (Annex I of MDR) that require the support of the clinical data.
- The intended purpose of the device.
- Intended target groups with indications and contraindications.
- Varied aspects required for the analysis and the conformity assessment of the clinical data.
- Intended clinical benefits with relevant and specified clinical outcome criteria.
- Methods to be used for the evaluation of qualitative and quantitative details of clinical safety with reference to the determination of residual risks and side effects.
- Identify and specify the criteria to be used to determine the acceptability of benefit-risk ratio for various indications and for the intended purpose of the device, based on state –of –art.
- If any specific components such as the use of medicinal substances, non-viable animal or human tissues are incorporated in the medical device, then how to address the related benefit-risk must be identified.
- Indication of the technique followed for the collection of clinical data for the clinical evaluation (equivalent device data or the device under evaluation data or the scientific literature).
- A clinical development plan with an indication of the progress from an exploratory investigation to a confirmatory investigation and to a PMCF with a clear indication of the milestone and description of potential acceptance criteria for each progression.
- Level of clinical evidence required for the demonstration of the conformity assessment of the general safety and performance requirement.
Since CEP helps in resource planning and helps improve operations, a manufacturer must seek professional help to get optimum solutions.
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