Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

Medicines Agency Consultation

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NB Expectations for Rule 21 Devices

• The Manufacturer has considered and identified the “functional” or “main ingredient(s) within the device • The Manufacturer’s technical documentation and data available to demonstrate • The ADME of the main constituent(s) • Data on the local tolerance & toxicity of the substance(s) • Consideration of potential interactions • other devices, medicinal products or other substances • Potential for adverse reactions • Labelling & IFU requirements met and appropriate for lay person use

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