Guidance

Devices which incorporate an ancillary medicinal substance

Guidance for notified bodies: devices which incorporate an ancillary medicinal substance

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NOTE: This is guidance that was first published in 2011 on the previous MHRA website. It is currently being updated and will be published shortly.

This Guidance is for Notified Bodies and their client companies wishing to consult the Medicines and Healthcare products Regulatory Agency (MHRA) with regard to the ancillary medicinal substance incorporated in a medical device.