clinical evaluation plan template

Clinical Evaluation Plan & Template

Clinical Evaluation Plan is a road map for conducting the clinical evaluation process. Since it contains the scope, methodological and systematic approach of how to proceed and reach a conclusion on the clinical evaluation.

The clinical evaluation plan is the first and foremost document to be prepared. It gives the stepwise planning for the activities to be carried out. This plan helps to continuously conduct and document a clinical evaluation. Chapter VI, Article 61 of the MDR details the relevant aspects to be considered for the critical evaluation of the clinical data that support the general safety and performance requirements. Towards the end of clause no. 1 has indicated for 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 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.
  • Different aspects required for the analysis and the conformity assessment of the clinical data.
  • Intended clinical benefits with relevant and specified clinical outcome parameters.
  • Methods to be used for the examination of qualitative and quantitative aspects of clinical safety with reference to the determination of residual risks and side-effects.
  • Identify and specify the parameters 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 ľof ľart.
  • If any specific components such as the use of pharmaceuticals, non-viable animal or human tissues are incorporated in the medical device, then how to address the related benefit-risk has to be identified.
  • Indication of the method 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.

MEDDEV 2.7.1 Rev. 4 is the guideline for the performing the clinical evaluation of a medical device that is before CE marking and after CE marked stage. It has a stage-wise explanation of the clinical evaluation.

Stage 0 contains the Scoping and the planning of the Clinical evaluation which specifies the contents as below:

  • Device description.
  • Intended purpose, Target group, an indication that requires any specific attention for the 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 which has clinical significance.
  • Applicable standards and guidelines available for the current knowledge and state of art, available medical alternatives for the target population.
  • Data source & 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.

Aspects to be considered for CE Marked Devices during Planning

  • Relevant changes in the design, 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, new knowledge about the potential hazards, risks, performance, benefits, and claims and any other aspects identified in the PMS.
  • Any need for planning PMS activities.

Clinical Evaluation Procedure, Plan and Template

You can purchase the Clinical Evaluation Procedure and the necessary template in word formats online. You can buy individual form and a complete set of documents also. Click Here.

Recent Client Testimonial:

Clinical Evaluation Plan Template Reviewed by Mr. Richard in . Best Clinical Evaluation Plan provided by MedDeviceCorp. The Template have all the relevant information related to clinical evaluation plan and procedure. Rating: 4.9