Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Annex IX – QMS and Tech Doc

Chapter III: Administrative Provisions ● Each Member State shall make provision that this documentation is kept at the disposal of the competent authorities for the period indicated in the first sentence of the preceding paragraph in case the manufacturer, or his authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of this period.

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The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes: Recap

 To understand the routes for conformity assessment  To understand the routes linked to the product classification  To understand the conformity assessment procedure for each route

The Organisation for Professionals in Regulatory Affairs

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