Medicines and Healthcare products Regulatory Agency
MHRA · United Kingdom · europe
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).
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- United Kingdom
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
Relevant Regulation Codes
- Medical Devices Regulations 2002 (SI 2002/618), as amended
- Medicines and Medical Devices Act 2021
- UKCA mark from 1 July 2024 (with CE recognition extended indefinitely for GB market under 2024 amendment SI)
Prescriber Requirements
- Prescription medical device — supplied on order of a GMC-registered doctor, NMC-registered nurse prescriber, GPhC-registered pharmacist independent prescriber, or HCPC-registered podiatrist within scope
- NHS application typically by tissue viability nurse under standing order; plastic-surgery indications by registered nurse on consultant ward
Supply Chain & GMP
Manufacturer / UK Responsible Person must register devices with MHRA via Device Online Registration System (DORS). GMP-equivalent traceability per ISO 13485. English labelling mandatory; cold chain 4–10 °C.
Import/Export Rules
Import to GB requires MHRA registration; Northern Ireland follows EU MDR under Windsor Framework. CITES Appendix II permit issued by UK CITES Management Authority (APHA). Live-invertebrate import additionally requires APHA veterinary clearance.
Reimbursement Context
NHS England Specialised Commissioning covers leech therapy under reconstructive-surgery service specifications (NHS England 13X05). NICE has not issued a Technology Appraisal — clinical practice guided by BAPRAS consensus.
Key Regulatory Documents
ASH Editorial Notes
Biopharm Leeches (Hendy, Wales) is the principal UK breeder and a globally significant supplier; supplies NHS plastic-surgery units and exports to FDA-regulated US market via Ricarimpex-parallel pathway.
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.
BfArM — Germany
Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.