Clinical Evaluation Plan

A Clinical Evaluation Plan is a structured document that outlines how a medical device will be clinically evaluated. It is a critical part of the clinical evaluation documentation as per the new MDR 2017/745.

A 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 clinical evaluation report. The CEP 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 of the clinical evaluation. Annex XIV, Part A specifically explains the details to be covered in the clinical evaluation plan.

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Role of Clinical Evaluation Consultants

Consultants and CER writers from I3CGlobal are highly sought after for their expertise in the development of Clinical Evaluation Plan due to several reasons

Our expertise in MDR Technical Documentation and clinical evaluations can ensure that the CEP meets these requirements, reducing the risk of Notified Body rejections or major non-conformity.
Our experience in Clinical Study Design including selecting appropriate endpoints, sample sizes, and statistical methods can help ensure that the study is well-designed and can provide meaningful results.
Our knowledge of Medical Devices and their clinical applications allows us to provide valuable insights into the clinical evaluation process.
Hiring the I3CGLOABL team adds Efficiency and cost Effectiveness can be more cost-effective than hiring a full-time employee, especially for smaller companies or projects that do not require a full-time clinical evaluation team.
The experience and expertise of the I3CGLOABL team can provide faster results in the clinical evaluation process, which can be valuable for companies that may be too close to the project end due to major issues identified by Notified Bodies.
I3CGLOBAL has access to the best global network of experts and resources that can be valuable for conducting the clinical evaluation, such as clinical trial sites, CROs, regulatory agencies, and other agencies to conduct post-market clinical follow-up etc.
Consultants can help identify and mitigate potential risks in the clinical evaluation process, reducing the likelihood of issues arising during regulatory review.

Overall, hiring a consultant for the development of a clinical evaluation plan and the creation of necessary templates and records can offer numerous benefits to companies in the medical device manufacturing industry.

Clinical Evaluation Plan Templates

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 template 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

CLICK HERE TO BUY TEMPLATES

Clinical Evaluation Plan Requirements

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 Guidance

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.

Clinical Evaluation Plan and Legacy Devices

The clinical evaluation planning phase requires careful planning and consideration of the specific challenges and limitations of these devices.

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 are 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.