Importer means any natural or legal person established in the Community market who places a device from a third country on the Community market.
In the EU, importers may only place devices on the market if they comply with the applicable legal requirements.
Before placing a medical device on the market, the importer shall ensure that
- the manufacturer has appointed an authorised representative;
- the manufacturer has drawn up the EU declaration of conformity and technical documentation;
- the device bears the required CE mark;
- the device is correctly labelled and accompanied by the necessary instructions for use and the EU Declaration of Conformity;
Where an importer considers or has reason to believe that a medical device does not comply with the requirements of the regulation, he shall not place that device on the market until conformity of the device has been established. Where the device presents a risk, the importer shall inform the manufacturer, his authorised representative and the competent authority of the Member State in which he is established.
In Austria, the importer is also obliged to report incidents in accordance with § 70 MPG. These reports must be sent to the BASG. In addition, the importer is obliged to cooperate in the implementation of field safety corrective actions (e.g. recall of medical devices, safety information or warning for users, etc.) and must also report these to the BASG.
If the importer is legally established in Austria, he must also register in the medical device register.