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February 3, 2026
Approximately 5 minutes
Obligations for Medical Device Importers and Distributors in Austria
Obligations for Medical Device Importers and Distributors in Austria
1. Definitions
An importer is any natural or legal person established within the Union that places a device from a third country on the Union market. A distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, that makes a device available on the market up until putting into service. Source: BASG Importer and Distributor Page https://www.basg.gv.at/en/medical-devices/importer
2. Registration
Importers and distributors must register via the Austrian Register for Medical Devices. Questions regarding registration should be directed to Gesundheit Österreich GmbH (GÖG) at medizinprodukte@goeg.at. Source: BASG Importer and Distributor Page https://www.basg.gv.at/en/medical-devices/importer
3. Medical Device Fee
Every person providing medical devices to end users in Austria must submit an annual fee declaration to BASG by June 30 for the previous year, per the Medical Device Fee Regulation. Source: BASG Importer and Distributor Page https://www.basg.gv.at/en/medical-devices/importer
4. General Obligations
Importers and distributors must comply with Articles 13 and 14 of MDR/IVDR, including:
- Immediately informing BASG of serious risks or falsified devices.
- Forwarding complaints and incident reports to the manufacturer.
- Maintaining registers of complaints, non-conforming devices, recalls, and withdrawals. Source: BASG Importer and Distributor Page https://www.basg.gv.at/en/medical-devices/importer
5. Vigilance Reporting
Serious risks, falsified devices, or suspected incidents must be reported immediately to BASG at medizinprodukte@basg.gv.at. Source: BASG Importer and Distributor Page https://www.basg.gv.at/en/medical-devices/importer
6. Inspections and Market Surveillance
BASG conducts announced or unannounced inspections. Companies must cooperate fully, providing access to premises, devices, records, and information. Source: BASG Importer and Distributor Page https://www.basg.gv.at/en/medical-devices/importer
7. Relabelled or Repackaged Devices
For activities under Article 16 MDR/IVDR, inform BASG at least 28 days in advance via medizinprodukte@basg.gv.at. Source: BASG Importer and Distributor Page https://www.basg.gv.at/en/medical-devices/importer
8. Contact
For inquiries: medizinprodukte@basg.gv.at Source: BASG Importer and Distributor Page https://www.basg.gv.at/en/medical-devices/importer
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