Module 18 - Drug Device Combinations and Other Technologies

Classification Rule 13

Classification rule 13 states that: • devices incorporating as an integral part, • a substance which used separately, can be considered to be a medicinal product • which is liable to act on the human body with action ancillary to that of the devices • are Class III.

Key issues: Is the substance a medicinal product in its own right? Is the medicinal substance acting in an ancillary manner? Is it liable to act on the body?

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Products on the drug-device borderline

Integral combination product (medicine)

Integral combination product (device)

Co-packaged drug & device

Non-integral, re usable (drug delivery) device

Applicable legislation

• Combination product falls under Medicines legislation • Device component to meet essential requirements for safety & performance

• Combination falls under Devices legislation • Consultation with Medicines authority required for medicinal component

• Drug and

• Drug and

device each fall under the

device each fall under the

respective legislation

respective legislation

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