Overview
A description of the device under evaluation and a clinical evaluation plan should be provided. Scope of the clinical evaluation should include the identification of devices covered by this clinical evaluation report, products, models, sizes, software versions, accessories, whether it is on the market, since when, in what regions, history of the device, in case of update in the plan including date of past modifications with reasons and description, sales volumes, changes since the last report, identification of the sections of the clinical evaluation report that are concerned with the new information and have been modified should be mentioned.
Evaluation of the clinical risks of devices
Risk management should address the significance of the residual risks remaining after mitigation. The regulatory status, reporting conducted, and estimates of the incidence of incidents reported in the PMS evaluation report should be considered.
To demonstrate the extent of the risk, the following factors should be considered.
· Nature severity, number and rates of harmful events associated with the use of the device.
· Device-related serious adverse events and incidents
· Device-related non-serious and non-reportable harmful events
· Procedure-related incidents
· Probability of a harmful event
· Duration of harmful events
· Risk due to false-positive or false-negative results from diagnostic medical devices.
The harmful events should be assessed in totality considering the severity of the aggregate effect of multiple harmful effects at once. Any hazard identified during analysis of clinical data not previously outlined in the risk management documentation should be provided with mitigation measures.
Clinical Evaluation Report
A clinical evaluation report should be compiled to document the clinical evaluation with a specified schedule.
It should provide enough detail for understanding the search criteria adopted, available data, all assumptions made, and all conclusions reached.
The contents of the clinical evaluation report are relevant to medical devices which should vary according to the nature and history of the device under evaluation.
The medical device clinical evaluation report should contain the following sections,
A Table of content
B Summary
C Scope of the clinical evaluation
· General details
· Device Description
· Device Classification
· Intended use
· Contraindication
· Warnings
· Precautions
· Device Status
· Identification of changes
D Clinical background, current knowledge, state of the art
· Clinical background
· Current knowledge and State of the art
E Device under evaluation
· Type of evaluation
· Demonstration of equivalence
· Identification of pertinent data
· Data generated and held by manufacturer
· Post market surveillance
· Post market surveillance outcome
· Post market clinical follow up
· Post market clinical follow up outcome
· Relevant Pre-clinical studies
· Biocompatibility testing (biological and clinical equivalence)
· Bench testing (technical and clinical equivalence)
· Electrical safety
· Software verification and validation
· Data retrieved from literature
F Summary and appraisal of clinical data
G Analysis of clinical data
· Requirement on Safety
· Requirement on Acceptable Benefit/Risk
· Requirement on Performance
· Requirement on acceptability of side-effects
H Clinical evaluation report conclusion
I Qualification of the responsible evaluators
J Date of next clinical evaluation
K CER Approvals
L Reference
Reference Document
• MDR 2017/745: Medical Device Regulation of the European Parliament and of the Council of 5 April 2017 on medical devices
• MEDDEV 2.7/1 Rev.4- Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC.
Conclusion
A Clinical Evaluation Report is required to demonstrate the safety and performance of the medical device, based on clinical data and other production and safety information. A Clinical Evaluation Report writer or consultant is necessary to compile, analyze, and present the clinical data clearly and comprehensively to the notified body. For more information, please contact the I3CGLOBAL team.
