For those Medical Devices which the manufacturer is not established in a Member State, the device may only be placed on the market under an Authorised Representative.
This Authorised Representative shall be designated by the manufacturer under a written mandate in which the tasks agreed between both parts are specified. This written mandate shall enable the Authorised Representative to perform the needed actions in order to guarantee the products’ conformity.
Bionok Healthcare works as Authorised representative for medical devices companies. This service allows foreign manufacturers to put their products on the European market with the peace of mind of knowing that your confidential information is in good hands.
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