Lægemiddelstyrelsen — Danish Medicines Agency
DKMA · Denmark · europe
Denmark's medicines agency — applies EU MDR for medical devices; leech-specific regulation has not been independently verified by ASH and is presumed to follow the general MDR framework.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Denmark
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
Relevant Regulation Codes
- Lov om medicinsk udstyr (Danish Medical Devices Act)
- Regulation (EU) 2017/745 (MDR) — direct effect
Prescriber Requirements
- Danish-authorised physician (læge) prescription required
- Specific scope of nurses and other allied health professionals for hirudotherapy not independently verified by ASH
Supply Chain & GMP
EU MDR-aligned registration with DKMA; Danish-language IFU; cold chain per manufacturer specifications.
Import/Export Rules
Intra-EU free movement. Third-country imports via DKMA notification and standard CITES Appendix II paperwork; Fødevarestyrelsen (Danish Veterinary and Food Administration) for live-invertebrate clearance.
Reimbursement Context
Public health system (Regioner) covers inpatient flap-salvage indications; specific outpatient hirudotherapy reimbursement category not independently verified by ASH.
Key Regulatory Documents
ASH Editorial Notes
Denmark's leech-specific clinical and regulatory practice has not been independently verified by ASH; the entry reflects expected EU MDR alignment. Confirm with local counsel before relying on 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.