Bundesamt für Sicherheit im Gesundheitswesen
BASG · Austria · europe
Austria's federal authority for safety in health care — applies EU MDR directly; leech-specific regulation has not been independently verified by ASH and is presumed to follow the general EU medical-device framework.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Austria
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.basg.gv.at
Relevant Regulation Codes
- Medizinproduktegesetz 2021 (MPG 2021) — Austrian implementation of MDR
- Regulation (EU) 2017/745 (MDR) — direct effect
Prescriber Requirements
- Physician (Arzt) prescription required under Austrian medical practice law
- Specific scope of non-physician practitioners (e.g., Heilmasseur) for leech therapy has not been independently verified by ASH
Supply Chain & GMP
EU MDR-aligned manufacturer / authorised representative registration via BASG / AGES Medizinmarktaufsicht; German-language labelling per Austrian consumer-protection law.
Import/Export Rules
Intra-EU free movement for CE-marked devices. Third-country imports require BASG notification plus standard CITES Appendix II paperwork for Hirudo medicinalis and live-invertebrate veterinary clearance.
Reimbursement Context
ÖGK (Österreichische Gesundheitskasse) coverage for inpatient indications via DRG bundling; specific outpatient hirudotherapy reimbursement status not independently verified by ASH.
Key Regulatory Documents
ASH Editorial Notes
Austria's leech-specific regulation has not been independently verified by ASH; the entry reflects the default EU MDR framework expected to apply. Austrian clinical use of hirudotherapy has historic anchor points in Vienna's traditional medicine community but precise regulatory references should be confirmed before relying on this entry for compliance decisions.
Related Jurisdictions
EMA — European Union
Centralised EU authority for medicinal products — leeches sit on the border between MDR-regulated device and HMPC traditional herbal medicine framework.
European Commission — European Union
EU executive body responsible for the Medical Device Regulation (MDR) — the legal instrument that frames how Member States CE-mark leech products.
MHRA — United Kingdom
Post-Brexit UK regulator — accepts EU CE marks during transition, with UKCA marking now phased in for Great Britain (Northern Ireland follows EU MDR via Windsor Framework).
BfArM — Germany
Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.