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Regulation on In Vitro Diagnostic Medical Devices

Official Journal Date : 9.01.2007
Official Journal Number : 26398

The objective of this Regulation is to lay down the essential requirements in vitro diagnostic medical devices and their accessories must meet and to establish the principles and procedures relating to their design, classification, manufacture, placing on the market, putting into service, and inspection for the purpose of providing safeguard measures for patients, appliers, users and third parties against possible hazards they may be exposed to as regards their health and safety during the use of such devices and their accessories.

Keyword related with the legislation item, a brief information of which is given above:
CE Marked Products, Importation of the Goods required to bear CE Mark, in vitro diagnostic medical devices, Directive no. 98/79/EEC, importation of in vitro diagnostic medical devices
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