Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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IVDR Annex II, main headings

1.2. Reference to previous and similar generations of the device

‘All submissions should be accompanied by a market history ...’

If the device is new and has never been marketed by the manufacturer anywhere in the world, state this explicitly.’

Provide an overview of identified similar devices available on the EU or international markets ... Provide a comparison of the key specifications.’

The Organisation for Professionals in Regulatory Affairs

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IVDR Annex II, main headings

● 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER ‘Provide the label or labels on the IVD for all variants; this includes … sales packaging labelling or transport packaging labelling, in the final approved version.’

The Organisation for Professionals in Regulatory Affairs

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