Module 19 2021

24/05/2021

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 – Where practical an example of the device – Data showing suitability of the device in view of intended purpose – Labelling and instructions for use – NB Issues Technical Documentation Assessment Certificate – Changes to product – may require pre-approval ● 5.2 Companion Diagnostics – NB consults with medicinal product CA or EMA (opinion within 60 days) – NB issues a technical documentation assessment certificate

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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 (QMS). 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 (TD required by Annex II

and III). and point (b) of Section 5.1., (ST/NPT) and – the decisions and reports from the notified body

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