Fimea — Finnish Medicines Agency
Fimea · Finland · europe
Finland's medicines agency — regulates medical devices including leeches under EU MDR; oversight transferred from Valvira to Fimea for medical devices effective 1 January 2020.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Finland
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.fimea.fi
Relevant Regulation Codes
- Laki lääkinnällisistä laitteista (719/2021)
- Asetus (EU) 2017/745 (MDR)
Prescriber Requirements
- Laillistettu lääkäri (licensed MD) prescription required
- Sairaanhoitaja (RN) application under standing order in hospital settings
- No statutory recognition of non-physician hirudotherapists
Supply Chain & GMP
MDR-aligned registration with Fimea via the medical-devices register. Finnish- and Swedish-language labelling mandatory. Cold chain per manufacturer IFU.
Import/Export Rules
Intra-EU free movement. Third-country imports through Tulli (customs) and Ruokavirasto (Finnish Food Authority) for live invertebrate clearance.
Reimbursement Context
Hyvinvointialueet (welfare regions, post-2023 reform) fund inpatient leech therapy via their hospital service budgets; no outpatient Kela reimbursement category.
Key Regulatory Documents
ASH Editorial Notes
Finland's medical-device oversight was moved from Valvira to Fimea on 1 Jan 2020 as part of regulator consolidation; this changes references in older 2018–2019 ASH content.
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.