Direction de la santé — Division de la Pharmacie et des Médicaments, Luxembourg
Luxembourg DPM · Luxembourg · europe
Luxembourg's Direction de la santé (Division of Pharmacy and Medicines) — leeches fall under EU medical-device frameworks (MDR 2017/745) as implemented through Luxembourgish national law; leech-specific national authorisation has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Luxembourg
- Leech status
- unregulated
- Last ASH review
- 2026-05-27
- Website
- https://sante.public.lu
Relevant Regulation Codes
- Luxembourg Law of 25 November 1982 on Medicinal Products, as amended
- EU Medical Device Regulation (MDR) 2017/745 — as transposed into Luxembourgish law
- Luxembourg Grand-Ducal Regulations on Medical Devices
Prescriber Requirements
- Luxembourg-licensed physician (under the Ministry of Health) — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Division de la Pharmacie registration as applicable; French and German-language labelling (with Luxembourgish supplementary information as relevant). Standard cold-chain conditions; EU intra-community movement under MDR applies.
Import/Export Rules
Free movement within the EU single market under MDR; Veterinary and Food Administration (ALVA) clearance for live invertebrates from non-EU origin; CITES Appendix II paperwork for Hirudo medicinalis / verbana on extra-EU import.
Reimbursement Context
Caisse Nationale de Santé (CNS) coverage depends on inpatient bundling; outpatient hirudotherapy is generally not separately reimbursed.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general EU MDR framework as transposed into Luxembourgish law. Luxembourg's regulatory practice is often closely harmonised with the Benelux partners (Netherlands MEB, Belgian FAMHP); whether this includes specific guidance on live-organism medical devices has not been independently mapped by ASH.
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.