Agence nationale de sécurité du médicament et des produits de santé
ANSM · France · europe
Home regulator of Ricarimpex SAS — the world's only leech manufacturer simultaneously CE-marked and FDA-cleared, operating under ANSM oversight since 1845.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- France
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://ansm.sante.fr
Relevant Regulation Codes
- Code de la santé publique, articles L.5211-1 et seq. (Dispositifs médicaux)
- Décret n° 2010-270 (matériovigilance)
- Règlement (UE) 2017/745 (MDR) — direct effect in France
Prescriber Requirements
- Prescription by médecin (MD), chirurgien-dentiste, or sage-femme within scope
- Application by infirmier diplômé d'État (IDE) under physician's order; specialised hirudotherapy training offered by Société Française d'Hirudothérapie
- Plastic-surgery indications: nursing teams in service de chirurgie plastique under standing-order protocols
Supply Chain & GMP
Notified Body certification (GMED, LNE/G-MED is the historic French NB); ANSM matériovigilance reporting under R.5212-14. Cold-chain 4–10 °C; French-language labelling under loi Toubon.
Import/Export Rules
Free intra-EU movement once CE-marked. Export to third countries (notably USA) via standard customs documentation referencing the K040187 510(k) and CITES export permits issued by Ministère de la Transition Écologique.
Reimbursement Context
Assurance Maladie reimburses inpatient use under T2A (tarification à l'activité); ambulatory reimbursement requires NGAP/CCAM coding — there is no dedicated CCAM code for leech application, so providers bill consultation + dispositif.
Key Regulatory Documents
ASH Editorial Notes
Ricarimpex SAS (Eysines, Gironde) holds the original 510(k) K040187 and a CE Class IIa certificate; ANSM has performed inspections under MDR. France is consequently a 'gold-standard' reference jurisdiction for global leech regulators.
Related Jurisdictions
FDA — United States
First regulator in the world to clear medicinal leeches as a medical device — Hirudo medicinalis cleared under K040187 (June 21 2004).
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).