Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

PSUR (C&D)/PMS (A&B)

CA (on request)

NB

EUDAMED3

A&B

C D

The notified body shall review the report and add its evaluation to that electronic system with details of any action taken.

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Responsibilities

• PMS is part of QMS • PRRC (manufacturer and AR) • Economic Operator contractual obligations have changed in IVDR (complaints, reports, corrective actions etc) • User reporting • EUDAMED

The Organisation for Professionals in Regulatory Affairs

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