Clinical Evaluation Template

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Clinical Evaluation (EU MDR 2017/745)
(Your company logo)
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Report Approval
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Table of Contents
1.0 Introduction ................................................................................................................ 3
2.0 Key Objectives ............................................................................................................ 4
3.0 Responsibilities ........................................................................................................... 4
4.0 Procedures .................................................................................................................. 5
4.1 Clinical Evaluation Plan ....................................................................................................... 5
4.2 Clinical Evaluation Process .................................................................................................. 7
4.3 Clinical Evaluation Report ................................................................................................... 8
4.4 Application Form for Clinical Investigation........................................................................... 8
4.5 Investigator’s Brochure ..................................................................................................... 11
4.6 Clinical Investigational Plan ............................................................................................... 13
4.7 Clinical Investigational Report ........................................................................................... 19
Red text = needs to be changed and write the information of the product
Grey text = add the text if it’s necessary according to the needs of product
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1.0 Introduction
According to the EU MDR 2017/745 clinical evaluation is a systematic process of collecting
and analysing clinical data of a medical device. The clinical information is collected from the
post-market surveillance (PMS) and specifically from the post-market clinical follow-up
(PMCF) and the clinical investigation. The aim of this is to provide the patients and the
healthcare professionals with confidence about the device which they are going to use. The
clinical evaluation process includes the clinical evaluation plan and report. Appendix A
illustrates the cases in which clinical investigation couldn’t be performed, if the device
doesn’t meet one of the cases then Section 4.4 to 4.7 of this template could be used in
order to complete: the clinical investigation plan and report, the Application form and the
Investigator’s Brochure.
The purpose of this document is to define the Clinical Evaluation process of product XXXX in
accordance with the EU MDR 2017/745.
The range of products are listed below (if necessary).
Range of Product (add and remove columns) XXXX XXXX
Medical Device Family/Category
Device Name(s)
Add any relevant information about the product
such as device identifier etc.
Device Description
Give a brief summary of the function of the device (usage of the device), a summary of the
warnings, the identification of product labelling, principles of operations etc. and attach the
design specification in the Appendices.