Essentials of European Medical Device Regulatory Affairs

Medical Device Accessories ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device; For example:- • Contact lens care products • Skin barrier powders and pastes for use with ostomy bags • Gases used to drive surgical tools

NOTE: Accessories treated as devices in their own right ! Ref: Council Directive 93/42/EEC

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Medical Devices for Drug Delivery

Examples:-

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

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