Module 18 2021

08/02/2021

Multifaceted Example

If the labelling for the device requires updating, does the labelling for the drug? ● If the products are based on the same indication(s), then yes .

What will this involve?

The Organisation for Professionals in Regulatory Affairs

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Multifaceted Example

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

The Organisation for Professionals in Regulatory Affairs

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