Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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Increased regulatory scrutiny under IVDR

IVD directive ~15% of IVD’s require intervention of notified body

IVDR ~85% of IVD’s require intervention of notified body (All except Class A)

The Organisation for Professionals in Regulatory Affairs

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Review of technical documentation under IVDD

Annex II Most technical files reviewed by NB

Non-Annex II Few if any technical files reviewed by NB

The Organisation for Professionals in Regulatory Affairs

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