Post Market Clinical Follow-Up (PMCF) Template

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Post Market Clinical Follow - UP (PMCF) (Your company logo)

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Table of Contents 1.0

Introduction..................................................................................... 3

2.0

Key Objectives ............................................................................... 3

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Responsibilities .............................................................................. 3

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Procedure ....................................................................................... 4

4.1 PMCF Plan ..................................................................................... 4 4.2 PMCF Review ................................................................................. 6 4.3 PMCF Report .................................................................................. 7 Appendix: Explanation of PMCF under the EU MDR 745/2017 .............. 8

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1.0 Introduction PMCF is a continuous process to update the clinical evaluation and address the post market surveillance plan. It's the manufacturer's obligation to collect and evaluate the clinical data from the use of the device. The aim of the assessment procedure is to ensure the safety and the performance of the device and identify any emergency risk.

The purpose of this document is to define the Post Market Surveillance (PMS) activities of the product XXXX. The range of products is listed below (if necessary).

Range

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remove XXXX

XXXX

columns ) Medical Device Family/Category Device Name(s) Add any relevant information about the product such as device identifier etc.

Device Description At this section 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 Appendances.

2.0 Key Objectives This document is aiming to establish the requirements of the PMCF including the PMCF plan, report and review of the product XXXX. 3.0 Responsibilities The manufacturer of the device XXX shall proactively collect and evaluate the clinical data from the users of the device XXXX.