Importer means any natural or legal person established within the Common Market who places a device from a third country on the Common Market.


Importers shall place on the Common Market only devices that are in conformity with the applicable legal framework.


Before placing a device on the market importers shall ensure the following:

(a) that the appropriate conformity assessment procedure has been carried out by the manufacturer;

(b) that an Authorised Representative has been designated by the manufacturer;

(c) that the EU declaration of conformity and the technical documentation has been drawn up by the manufacturer;

(d) that the device bears the required CE marking of conformity;

(e) that the device is labelled in accordance with the legal requirements and accompanied by the required instructions for use and EU declaration of conformity;


Where an importer considers or has reason to believe that a device is not in conformity with the legal requirements, he shall not place the device on the market until it has been brought into conformity.

Where the device presents a risk, the importer shall inform the manufacturer and his Authorised Representative to that effect, as well as the competent authority of the Member State in which he is established.

Created: 10.11.2014 | Page last modified: 25.01.2016

© Austrian Federal Office for Safety in Health Care
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