Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Topics

• The Intended Purpose • The Performance Evaluation Plan

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Intended Purpose

• The Definition in Art. 2

(12) ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation;

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