College ter Beoordeling van Geneesmiddelen — Medicines Evaluation Board
MEB / CBG · Netherlands · europe
Dutch Medicines Evaluation Board — paired with IGJ (Health and Youth Care Inspectorate) for device oversight; leech-specific regulatory pathway in the Netherlands has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Netherlands
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.cbg-meb.nl
Relevant Regulation Codes
- Wet op de medische hulpmiddelen (Dutch Medical Devices Act)
- Regulation (EU) 2017/745 (MDR) — direct effect
Prescriber Requirements
- BIG-registered arts (physician) prescription required under Dutch Individual Health Care Professions Act (Wet BIG)
- Non-physician practitioner scope for hirudotherapy (e.g., natuurgeneeskundige) has not been independently verified by ASH
Supply Chain & GMP
EU MDR-aligned registration; Dutch-language IFU per consumer-protection law. Cold chain per manufacturer specifications.
Import/Export Rules
Intra-EU free movement for CE-marked devices. Third-country imports through IGJ notification with standard CITES Appendix II paperwork and NVWA (food and consumer product safety authority) veterinary clearance.
Reimbursement Context
Dutch basic health insurance (Zorgverzekeringswet, Zvw) reimburses indications listed in the Zorgverzekering basispakket; specific hirudotherapy coverage status not independently verified by ASH and is likely limited to inpatient flap-salvage settings.
Key Regulatory Documents
ASH Editorial Notes
Note: MEB / CBG is primarily a medicines regulator; medical-device oversight in the Netherlands is shared with IGJ (Inspectie Gezondheidszorg en Jeugd). The leech-specific regulatory pathway has not been independently verified by ASH and should be reviewed by Dutch counsel before relying on for compliance.
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.