Module 18 - Drug Device Combinations and Other Technologies

Are these medical devices?

Deep Heat gel: NO – it’s a medicinal product with analgesic properties

Toothbrush: NO – it is a hygiene product

Pill dispenser: NO - it’s a memory aid but not a medical device

(cosmetic purpose)

Safety glasses: NO – these are PPE

Eye protection

Incontinence pads: YES, these are a medical device

Tattoo needles: NO – these don’t have a medical purpose

Acupuncture needles: YES, these are a medical device

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Guidance Documents

MHRA Guidance:

https://www.gov.uk/guidance/borderline-products-how-to-tell-if your-product-is-a-medicine https://www.gov.uk/guidance/borderline-products-how-to-tell-if your-product-is-a-medical-device https://www.gov.uk/government/publications/borderlines-between medical-devices-and-medicinal-products https://www.gov.uk/government/publications/borderlines-with medical-devices MHRA Medical device stand-alone software including apps (& IVDMDs)

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