Clinical Evaluation Plan

Clinical evaluation plan play a crucial role in the CER documentation as per article 61 and MEDDEV 2.7.1 Rev 4 by providing a structured approach. A Clinical Evaluation Plan typically includes the following requirements:

• 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 are 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 concerning the determination of residual risks and side effects.
• Identify and specify the criteria to be used to determine the acceptability of the benefit-risk ratio for various indications and the intended purpose of the device, based on state –of –art.
• If any specific components such as the use of medicinal substances, or non-viable animal or human tissues are incorporated into 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 a post-market clinical follow-up 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.

The clinical evaluation plan should be identified in the technical documentation. The CEP can be presented in an easily identifiable way either as a separate document or as part of the clinical evaluation report.

MEDDEV 2.7/1 Rev. 4 is the guidance document for performing the clinical evaluation of medical devices before CE marking and after the CE marked stage. This guidance provides a stage-wise explanation of the clinical evaluation where Stage 0 points out the scoping and the planning which specifies the contents as given below:

• Device description.
• Intended purpose, Target group, an indication that requires any attention for safety and performance.
• The specific application of the device targets the treatment group and disease proposed warnings, contraindications, precautions, and method of application.
• Specific claims made by the manufacturer about clinical safety & performance.
• Residual risk has clinical significance.
• Relevant standards and guidelines available for the current knowledge and state of art, available medical alternatives for the target population.
• Source of data and types of data to be used in clinical evaluation.
• All the above aspects need to be covered for both (a) before CE Marking and (b) already CE Marked for medical devices.
• Information needed for evaluation of equivalence, if it is claimed has also be considered for the before CE marking devices.