Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Annex IX – QMS and Tech Doc

Chapter II: Assessment of Technical Documentation ● 5. Specific types ● 5.1. Class C self-tests and Class B and C near-patient tests – Test reports, including studies with intended user – Data showing suitability of the device in view of intended purpose – NB Issues Technical Documentation Assessment Certificate – Change of product ● 5.2 Companion Diagnostics – NB consults with medicinal product CA or EMA – …

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The Organisation for Professionals in Regulatory Affairs

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Annex IX – QMS and Tech Doc

Chapter III: Administrative Provisions ● Manufacturer or AR keep at the disposal of CA for at least 10 years after the last device has been placed on the market: – the declaration of conformity, – the documentation referred to in the fifth indent of Section 2.1. and in particular the data and records arising from the procedures referred to in point (c) of Section 2.2., – the changes referred to in Section 2.4., – the documentation referred to in Sections 4.2. and point (b) of Section 5.1., and – the decisions and reports from the notified body

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