Module 15 2022

5/19/2022

The PMS Process

PMS

Key MDR requirements:

P ost M arket S urveillance

 Requirement for all devices

 Active, systematic continuous process

 Proportionate and appropriate for the device and risk class

 Feedback into multiple processes

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The PMS Process

PMS

Risk management

Updates to:

Benefit risk CEP/CER IFU Labelling SSCP

Central process

Clinical Evaluation

Design

PMS

Technical Documentation PMS Plan

Manufacture

PMCF

Report/PSUR PMCF Plan PMCF Report

CAPA/FSCA

Trend reporting

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