European Commission — DG SANTE
European Commission · European Union · europe
EU executive body responsible for the Medical Device Regulation (MDR) — the legal instrument that frames how Member States CE-mark leech products.
Regulatory Profile
- Agency type
- supranational
- Region
- europe
- Country
- European Union
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
Relevant Regulation Codes
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- Commission Implementing Regulation (EU) 2017/2185 (UDI rules)
- MDCG Guidance 2019-11 — Classification of medical devices
Prescriber Requirements
- Out of scope — sets product-market rules, not prescriber scope
Supply Chain & GMP
Manufacturer responsibilities under MDR Art. 10; Person Responsible for Regulatory Compliance (PRRC) under Art. 15; UDI registration in EUDAMED; post-market surveillance plans under Art. 83.
Import/Export Rules
EU customs union — once a device is CE-marked it has free movement across Member States. Import from third countries requires CE certificate plus the standard CITES / TRACES live-invertebrate paperwork.
Reimbursement Context
EC does not set reimbursement; this is national competence under TFEU Art. 168.
Key Regulatory Documents
ASH Editorial Notes
The MDR transition period extension (Regulation (EU) 2023/607) keeps legacy MDD certificates valid through Dec 2027 for Class IIa devices in compliance with the new GSPRs — relevant for Ricarimpex's CE certificate.
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.
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.
ANSM — France
Home regulator of Ricarimpex SAS — the world's only leech manufacturer simultaneously CE-marked and FDA-cleared, operating under ANSM oversight since 1845.