Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Multifaceted Examples

For the Device: • The labelling for the device requires updating • This will need to be filed as part of the STED, and • May need to be reviewed by the Notified Body ● A field safety notice may need to be issued to inform users ● Does this impact the way treatment is performed? ● are there any impacts on the software? For the Drug Product: • A variation to update the SmPC and PIL would be required. • If the product is part of a DCP/MRP, then this will involve all the relevant countries and national labelling

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Multifaceted Example

Points for consideration • A change affecting one part of the Drug-Device combination, may impact on the other • For Example 2: • CMC/TPP aspects of Near Patient Manufacture will/may have to be clarified through scientific advice from EMA and/or specific country CA • Risk Management file for the medical device has to identify all primary and secondary risks associated with the change. …therefore the wider implications of any change should always be considered

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