Module 18 - Drug Device Combinations and Other Technologies

Multiple Choice!

Some products could come under various regulations – e.g. medicinal product, medical device, biocide, cosmetic, general products. The key to these determinations will depend upon the product’s mode of action and intended purpose.

e.g.: Eye drops

Emollient Creams Hand sanitizer

37

37

IVD Borderlines

Not all InVitro 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)

• MEDDEV 2.14/1 rev.2

38

38

19