Essentials of European Medical Device Regulatory Affairs - October 2019

Integral Products (which are medicines)

Examples:-

• Prefilled syringes/pens • Aerosols containing a medicinal substance • Pre-charged nebulizers • Implants that release a medicinal product • Patches for transdermal drug delivery

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Integral Products (which are devices)

Definition:-

Device that incorporates, as an integral part, a substance .. if used separately, may be considered .. a medicinal product .. and which is liable to act on the body with action ancillary to that of the device

Regulated as device: 93/42/EEC article 1(4)

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