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February 10, 2026
Approximately 5 minutes
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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