English
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
Qualification: how to prove it
Medizinprodukte is a regulated trade under §94 Z.29 of the Austrian Trade Act (GewO 1994). The standard route is the qualification exam (befähigungsprüfung).
- Examined by: WK
- Exam modules: 5
- Exam fee: €0 — exam fees are covered by the federal government
If you cannot sit the exam, these routes are open to you:
- Individual assessment under §19 GewO
- Appointing a qualified managing director
Registering the trade
- Cost: Free — registration itself carries no fee
- Where: District administrative authority (Bezirksverwaltungsbehörde)
- Decision within: max. 3 months
- Typically takes: 1-5 Werktage (bei vollstaendigen Unterlagen)
- Start trading: immediately on registration — you do not have to wait for the decision
You can register in these ways:
- Online via GISA (the trade register)
- Online via USP (the business service portal)
- In person at the authority
Who may register
- Minimum age: 18
- Citizenship or residence: Austria, EU, EEA or Switzerland
- Clean record: no disqualifying convictions (checked by the authority)
Documents to bring
- Photo ID
- Certificate of competence (Befähigungsnachweis)
- Criminal record certificate
Terms shown in German are the ones printed on the Austrian forms — you will meet them exactly like this at the authority.
Where to go, by province
| Province | Competent authority |
|---|---|
| Vienna | Magistrat der Stadt Wien, MA 63 |
| Lower Austria | Bezirkshauptmannschaft |
| Upper Austria | Bezirkshauptmannschaft / Magistrat Linz/Wels/Steyr |
| Styria | Bezirkshauptmannschaft / Magistrat Graz |
| Tyrol | Bezirkshauptmannschaft / Magistrat Innsbruck |
| Salzburg | Bezirkshauptmannschaft / Magistrat Salzburg |
| Carinthia | Bezirkshauptmannschaft / Magistrat Klagenfurt/Villach |
| Burgenland | Bezirkshauptmannschaft |
| Vorarlberg | Bezirkshauptmannschaft / Magistrat Bregenz |
Legal basis: GewO 1994 §94 Z.29 . Last reviewed April 2026. This is not legal advice.
Legally binding: German text of GewO 1994.