accessory
as defined in Directive 98/79/EC of the European Parliament and of the Council of 27 October…, Article 1(2), point (c)
an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose. For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices;
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Also defined in
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 31993L0042, Article 1(2), point (b)
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