Module 15 Presentations

4/15/2024

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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© NAMSA 2021

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MEDDEV 2.7.1 Rev 3 (2009)  Rev 4 (2016)

“MEDDEV 2.7.1 rev 4 does not contain new criteria, but represent further explanations of the those introduced by Directive 2007/47/EC. These criteria were already explained in MEDDEV 2.7.1 rev 3 which has been published seven years ago.”

MEDDEV 2.7.1 Rev 3

MEDDEV 2.7.1 Rev 4

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© NAMSA 2021

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