The Medical Devices Introductory Course 2020

Class A & B

Class C

Class D

PMS Report

PSUR

PSUR

Updated when necessary

Updated at least annually

Updated at least annually

Made available to NB and on request to CA

Made available to NB and on request to CA

Made available to NB for evaluation, made available to CA (incl. NB evaluation) via Eudamed

The Organisation for Professionals in Regulatory Affairs

Post Market Surveillance

IVD Labelling

Labelling is any information provided by the manufacturer relating to the IVD device. This can include:

Product Labels

Marketing Material

Packaging

Consider the claims presented relating to safety and performance of the device.

ISO18113 series – Information supplied by the manufacturer

The Organisation for Professionals in Regulatory Affairs