Module 18 2021

IVD Borderlines

Not all In Vitro Diagnostic products are IVD medical devices: • Research use only products • General Laboratory equipment

Some apparent IVD medical devices may not be: • If there is invasive body contact (e.g. lancets, needles, mouth tubes for lung function tests) • Where no ‘sample’ is taken • Breathalysers and tests for recreational drugs (not medical devices if only for legal or employment purposes)

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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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