PMCF plan Template EU MDR 2017/745 - Easy Medical Device

PMCF Plan Template

0,00€

This PMCF plan Template provided to you by Easy Medical Device is taking into account the MDCG 2020-7 guidance.

Some elements of it were improved to provide more guidance to the medical device manufacturers. This document is available in DOCX format and contains 13 pages. It includes guidance text in blue and links to external documents. The format is provided to you to match normal procedure requirements per ISO 13485.

This document is only a template and should be updated prior to use. A Regulatory Affairs professional needs to review that to be sure that all elements are aligned.

SKU: EMD-010 Category:
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The PMCF plan is needed per EU MDR 2017/745. But before having a PMCF plan, a Clinical Evaluation Report should be provided. The PMCF is helping you to gather clinical data when your device that is already CE marked is used per indication. These data should prove that your device is still safe and efficient.

You need to have a Technical File and Clinical Evaluation Report to be able to complete some of the elements of this template.

You can also buy the Bundle Tech File + GSPR + DoC to help you. 

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