Essentials of European Medical Device Regulatory Affairs

Medicinal Product or a Medical Device? Depends on mode of action of the Product to achieve its indication

Primary Intended Purpose achieved by one of the following means:

Primary intended purpose achieved by other means:

Pharmacological Metabolic Immunological All ATMPs All In-Vivo Diagnostics

Physical Simple Chemical Mechanical Digital

Medical device

Medicinal Product

Ancillary Drug

Deliver/ Localise

Device-Drug Combination

Drug-Device Combination

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Device or Medicine ?

Consider the manufacturer’s claim

• Device – NOT by pharmacological, immunological or metabolic means • Medicine – correcting or modifying physiological functions

Device action tends to be physical e.g. a support or barrier.

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