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

‘Only marketing literature that mention that the device fulfils the requirements of CE marking or includes the CE mark itself is required to be provided.’ ‘Claims made in the marketing literature must be consistent with the IFU and consistently displayed in the submitted technical documentation.’

The Organisation for Professionals in Regulatory Affairs

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IVDR Annex II, main headings

3. DESIGN AND MANUFACTURING INFORMATION – 3.1. Design information – ‘Where the device uses software … provide a description of the data interpretation methodology i.e., analysis algorithm’ – For devices containing raw materials

of human, animal or microbial origin, a Certificate of Analysis (CoA) must be submitted

The Organisation for Professionals in Regulatory Affairs

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