Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Work in progress

https://health.ec.europa.eu/medical-devices sector/new-regulations/guidance-mdcg

endorsed-documents-and-other-guidance_en

7

Post Market

Prompt

Process

Action

Report

Incident(s)

Vigilance

Analyse

MIR

Incident/control

Vigilance

FSCA

FSN

Planned

Post Market Surveillance

Analyse

PMS/PSUR

Competent Authority/ Commission

Market Surveillance

Analyse > Compliance/ Enforcement

EUDAMED

8

4