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Medical Device Trade (Medizinprodukte)
GewO §94 Z.43
Verified: April 2026
Key Facts
- Type: Regulated trade
- Qualification: Qualification exam (Befaehigungspruefung)
- Registration cost: Free (€0)
- EU regulation: Medical Device Regulation (MDR 2017/745) applies
- Note: Manufacturing requires separate CE marking procedures
What This Trade Covers
- Sale and distribution of medical devices
- Custom-made medical devices (e.g., prosthetics, orthotics)
- Maintenance and servicing of medical equipment
- Fitting and adaptation of devices to patients
- Import and wholesale of medical devices
EU MDR Compliance
Since May 2021, the EU Medical Device Regulation (MDR 2017/745) applies
to all medical devices on the Austrian market. This brings stricter
classification, traceability (UDI), and post-market surveillance
requirements beyond the trade license itself.
Overlap with Other Trades
Several regulated trades produce medical devices under their own license (e.g., orthopedic shoemaker, orthotics maker, dental technician, hearing aid acoustician). This standalone license covers devices not already covered by another specific trade.
Related Guides
Legally binding: German text of GewO 1994.