Module 19: Regulation of In Vitro Diagnostic Medical Devices

18/04/2023

1. Product Classification

IVDD: List of high-risk disease states and conditions IVDR: Classification more on intended use, intended purpose Devil is in the detail Go/No-go decisions are being made

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2. Technical Documentation

• Annex I – General Safety and Performance Requirements • Annex II – Technical Documentation • Annex III – Post Market Surveillance

• Potential significant investment in time and resource • Harmonised approach with IMDRF STED • EU market access no longer the easy pathway

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