Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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IVDR Annex II, main headings

● 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER ‘Manufacturers must ensure that the information within the IFUs, especially related to intended purpose, indications, contra-indications, and other safety related information, warnings is aligned with similar information from other sections such as risk management, performance evaluation, usability etc.’

The Organisation for Professionals in Regulatory Affairs

25

26

IVDR Annex II, main headings

● 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER ‘Manufacturers’ ‘If a safety data sheet (SDS) is provided for the device, the SDS is part of the Technical Documentation …’ ‘Note that instructions for obtaining the SDS shall be included on the label or instruction for use’

The Organisation for Professionals in Regulatory Affairs

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