Distributor means any natural or legal person in the supply chain who makes a medical device available on the Community market, other than the manufacturer or the importer. When placing a device on the market, distributors shall take due care of the applicable requirements.
Before placing a device on the market, distributors shall verify that the following requirements are met:
- The device bears the required CE mark;
- The information provided by the manufacturer is enclosed with the medical device.
If a distributor considers or has reason to believe that a medical device does not comply with the legal requirements, he shall not make the device concerned available on the market until the conformity of the device has been established. Where the product presents a risk, the distributor shall inform the manufacturer and, where appropriate, his authorised representative and the importer, as well as the competent authority of the Member State in which he is established.
While a device is under the responsibility of the distributor, he shall ensure that the storage or transport conditions do not affect the conformity of the device with the essential requirements listed in Annex I.
Distributors who receive complaints and reports from health-care professionals, patients or users about suspected incidents in relation to a device shall immediately forward them to the manufacturer and, where appropriate, his authorised representative.
In Austria, distributors are also obliged to report incidents in accordance with § 70 MPG. These reports must be sent to the BASG. In addition, distributors are 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 distributor is legally established in Austria, he can register in the medical device register.