Essentials of European Medical Device Regulatory Affairs - June 2020

Medical Device Accessories ‘accessory’ whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical devices to specifically enable the medical device to be used in accordance with its intended purpose ….. For example:- • Contact lens care products • Skin barrier powders and pastes for use with ostomy bags • Gases used to drive surgical tools

NOTE: Accessories are treated as devices in their own right.

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Medical Devices for Drug Delivery

Examples:-

• An empty syringe • Drug delivery pump • Nebulizers • Medicine Spoons • ‘Lock out’ tablet dispensers

TheOrganisation for Professionals in 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

TheOrganisation for Professionals in Regulatory Affairs

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