Clinical Evaluation Plan

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Clinical Evaluation Plan

Clinical Evaluation Plan For Medical Devices

The medical devices that require demonstrating the safety and performance with the help of clinical data

A Clinical Evaluation Plan (CEP) is a detailed document that outlines the systematic approach and strategy for evaluating the clinical performance and safety of a medical device. It serves as a roadmap for conducting clinical evaluations throughout the device’s lifecycle, from initial development to post-market surveillance.

The CEP is an essential part of the regulatory submission process, providing evidence to demonstrate the device’s safety, performance, and compliance with regulatory requirements. The purpose of a Clinical Evaluation Plan is to gather and assess clinical data to support the device’s safety and efficacy claims. It involves a comprehensive analysis of existing scientific literature, clinical investigations, post-market surveillance data, and other relevant sources of clinical evidence. The CEP helps establish the scientific validity, clinical performance, and risk-benefit profile of the medical device.

To develop the scope of the clinical evaluation to be conducted on the medical device, as well as to plan a sound method for identifying, collecting, and analyzing clinical data with the proper schedule and clinical evaluation team.

Clinical Evaluation Plan Template MDR

The clinical evaluation should begin with a well-organized clinical evaluation plan. The following details must be included.

Medical Device Information

Before beginning the plan, the medical device details, such as the general description, characteristics, and claims, should be determined.

Scoping of Clinical Evaluation Plan

Scoping of the clinical evaluation is the first and the foremost step

Pertinent data from Clinical Investigation

Ensure an effective and high-value clinical engagement with available data

Pertinent data from literatures or PMS/PMCF study

Ensure an effective and high-value clinical engagement with available data

The Clinical Evaluation Plan

Should be established and updated based on the aspects of general safety and performance requirements

List of responsible personnel

List of responsible personnel for the different Clinical evaluation activities with a planned schedule must be created

MDR Clinical Evaluation Plan Requirements

The Clinical Evaluation Plan should be established and updated based on the aspects as listed below:

Information of start date, expected completion date and that of the responsible personnel involved in the clinical evaluation
an identification of the general safety and performance requirements that require support from relevant clinical data;
a specification of the intended purpose of the device;
a clear specification of intended target groups with clear indications and contra-indications;
a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;
a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects;
an indicative list and specification of parameters to be used to determine, based on state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and the intended purpose or purposes of the device;
an indication of how benefit-risk issues relating to specific components such as the use of pharmaceutical, non-viable animal or human tissues, are to be addressed; and
a clinical development plan should indicate progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF with an indication of milestones and a description of potential acceptance criteria.
A list of responsible personnel for the different Clinical evaluation activities with a planned schedule must be created.

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