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February 10, 2026
Approximately 5 minutes
Obligations for Medical Device Distributors and Importers in Finland
Obligations for Medical Device Distributors and Importers in Finland
1. General Obligations
Distributors and importers must ensure that medical devices comply with MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) requirements when making them available on the Finnish market. This includes verifying CE marking, authorised representative, UDI, and proper labelling/packaging. Source: Fimea Device Distributors and Importers Page https://fimea.fi/en/medical-devices/device-distributors-and-importers
2. Verification and Compliance Checks
Before making a device available:
- Verify CE marking and declaration of conformity.
- Ensure instructions for use and labelling are provided.
- Check proper storage and transport conditions.
- Confirm registration in EUDAMED (where applicable). If non-compliant, inform the manufacturer/authorised representative and suspend distribution. Source: Fimea Device Distributors and Importers Page https://fimea.fi/en/medical-devices/device-distributors-and-importers
3. Language Requirements
For devices intended for lay users, instructions for use and labelling must be in Finnish and Swedish. For professional use devices, English is acceptable, but Finnish/Swedish is recommended where possible. Source: Fimea Device Distributors and Importers Page https://fimea.fi/en/medical-devices/device-distributors-and-importers
4. Vigilance and Incident Reporting
Distributors and importers must forward complaints and incident reports to the manufacturer/authorised representative and Fimea if serious. Cooperate in field safety corrective actions. Source: Fimea Device Distributors and Importers Page https://fimea.fi/en/medical-devices/device-distributors-and-importers
5. Registration and Market Surveillance
No national registration requirement for distributors/importers beyond EUDAMED obligations. Fimea conducts market surveillance, including inspections. Contact: medicaldevices@fimea.fi Source: Fimea Device Distributors and Importers Page https://fimea.fi/en/medical-devices/device-distributors-and-importers
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