Direktoratet for medisinske produkter — Norwegian Medical Products Agency
DMP · Norway · europe
Norway's medical products agency (formerly Statens legemiddelverk, rebranded DMP in 2024) — applies EU MDR via EEA Agreement; leech-specific regulation has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Norway
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.dmp.no
Relevant Regulation Codes
- Lov om medisinsk utstyr (Norwegian Medical Devices Act)
- Regulation (EU) 2017/745 (MDR) — incorporated via EEA Agreement
Prescriber Requirements
- Norwegian-authorised lege (physician) prescription required
- Scope of non-physician practitioners (e.g., alternativ behandler under Lov om alternativ behandling) for hirudotherapy not independently verified by ASH
Supply Chain & GMP
EU MDR-aligned registration with DMP; Norwegian-language IFU; cold chain per manufacturer specifications.
Import/Export Rules
EEA free movement for CE-marked devices. Third-country imports through DMP notification, Mattilsynet (Norwegian Food Safety Authority) for live-invertebrate clearance, and standard CITES Appendix II paperwork.
Reimbursement Context
Helseforetak (regional health enterprises) cover inpatient flap-salvage indications; specific outpatient hirudotherapy reimbursement under Helfo (HELFO) not independently verified by ASH.
Key Regulatory Documents
ASH Editorial Notes
Statens legemiddelverk was rebranded as Direktoratet for medisinske produkter (DMP) effective 1 January 2024. Norway participates in the EU MDR framework via the EEA Agreement but is not an EU Member State; specific leech regulatory practice has not been independently verified 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.