Essentials of European Medical Device Regulatory Affairs

Medicinal Products

Examples:-

• Spermicidal preparations • Gases used in anaesthesia • Topical disinfectants • Toothache preparations (i.e. Eugenol) • Water for injections, IV fluids • Antacids • Artificial tears (medicated) • Root canal dressings

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Integral Products (which are medicines)

Definition:-

• Devices for administration of medicinal products such that the device and the medicinal product form a single integral product designed to be used exclusively in the given combination and which is not reusable.

Regulated as medicines: 2001/83/EEC .

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