Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The device's intended purpose (continued):

Which information in the Intended Purpose?

• (iv) whether it is automated or not; • (v) whether it is qualitative, semi quantitative or quantitative; • (vi) the type of specimen(s) required; • (vii) where applicable, the testing population; and • (viii) for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test.

Annex I. 20.1.4.c

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Once upon a time… under the Directive

• Many Intended Use statements were purely analytical • Not compliant with IVD Regulation

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