Medical Device Trade (Medizinprodukte)
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
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.33 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 vollständigen 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 |
Sole trader, GmbH, or partnership?
Trade law does not prescribe a legal form — but it does draw one line. Under § 9 (1) GewO, legal entities and registered partnerships (GmbH, OG, KG) may hold a trade licence, but they „must have appointed a managing director (§ 39)“ — a named person who carries the qualification and the legal responsibility for the trade. As a sole trader you are that person yourself.
Whether a GmbH pays off financially depends on profit, drawings, SVS contributions and allowances. There is no general profit threshold, and that question belongs to a tax adviser, not to this page.
Running this trade alongside a job
Nothing in Austrian law forbids running a trade as a side business. Two things about social insurance are regularly misremembered, and both cost money.
- The obligation follows Chamber membership, not profit. Under § 2 (1) 1 GSVG compulsory SVS insurance attaches to membership of the Economic Chamber, which you acquire with the trade licence itself. It therefore applies in a year in which you make no profit at all.
- There is an exemption — but only on application. § 4 (1) 7 GSVG lets very small businesses be exempted while turnover and income stay under the limits it refers to. Nothing happens automatically: without the application, the obligation stands.
If you are employed, check your employment contract separately for a secondary-activity clause — that is a matter between you and your employer, not trade law.
Legal basis: GewO 1994 §94 Z.33 . Last reviewed April 2026. This is not legal advice.