Clinical Evaluation Plan
The clinical evaluation plan is a road map for conducting the clinical evaluation process. It includes the scope, methodological, and systematic approach on how to proceed and reach a conclusion on the evaluation, to document it in a CER.
The clinical evaluation plan is the first and the principal document to be prepared. It gives stepwise planning for the activities to be carried out. This plan helps to continuously guide and document a 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 GSPR. Towards the end of clause no. 1 has indicated the planning, conducting, and documenting the clinical evaluation. Annex XIV, Part A specifically explains the details to be covered in the clinical evaluation plan.
Clinical Evaluation Plan 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 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 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.
Clinical Evaluation and Stage 0 of MEDDEV 2.7/1 Rev.4
MEDDEV 2.7/1 Rev. 4 is the guidance document for performing the clinical evaluation of a medical device 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 target 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 medical devices.
- Information needed for evaluation of equivalence, if it is claimed has also be considered for the before CE-marking devices.
Based on MEDDEV 2.7/1 Rev. 4 and MDR article 61 prescribed format, our team of experts has developed a clinical evaluation procedure and template of EU MDR Clinical Evaluation Plan covering all the requirements. Manufacturers or their regulatory personnel can buy from us online. Suitable for Small and Medium sized companies with less Regulatory professionals
Major consideration for CE Marked Devices during Clinical Evaluation
- Significant changes in the design, raw materials, manufacturing processes, information materials supplied by the manufacturer or other claims, and any claims related to the equivalence.
- Any specific clinical concerns that have newly emerged and that need to be addressed.
- PMS aspects to be updated with the new clinical data, recent knowledge about the potential hazards, risks, performance, benefits, and claims, and any other particulars identified in the PMS.
- No need for planning PMS activities.