If the manufacturer of a medical device has his place of business outside the Community market, he must designate an authorised representative. The designation must be made in writing and must also be reconfirmed in writing by the authorised representative.
The authorised representative must appear on the label and in the instructions for use.
For manufacturers not established in the Community market, the authorised representative plays a crucial role in ensuring the conformity of medical devices. He must cooperate with the national authorities and provide the relevant documents for the medical device (declaration of conformity, technical documentation, etc.).
In Austria, the authorised representative is additionally obliged to report incidents in accordance with § 70 MPG. These reports must be sent to the BASG. In addition, the authorised representative 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 authorised representative is legally established in Austria, he must also register in the medical devices register.