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February 10, 2026
Approximately 5 minutes
Finland's CERE Register: When and How to Notify Operators and Devices Outside EUDAMED
Finland's CERE Register: When and How to Notify Operators and Devices Outside EUDAMED
1. Overview of CERE Register
CERE is Finland's national register for medical device operators and devices, maintained by Fimea. Certain operators established in Finland are required to submit notifications to CERE under national legislation, particularly those not obligated to register in EUDAMED. Notifications can be made via e-submissions (preferred where available) or PDF/Excel forms. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
Contact for questions: [email protected]. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
2. Operators Required to Notify to CERE
Finnish-established operators must notify CERE if they fall into these categories (and are not required to use EUDAMED):
- Manufacturers of custom-made devices (excluding class III implantable devices where a notified body was involved in conformity assessment)
- Health institutions manufacturing devices for in-house use (self-manufacturers; all devices covered in a single notification per institution)
- Distributors making devices available to professional users in Finland (temporary exemption: device notifications not required until further notice)
- Sterilisation service providers (for CE-marked devices; in-house units exempt unless serving manufacturers; notify via free-form email)
- Manufacturers of non-medical purpose devices (MDR Annex XVI)
- Distributors (including abroad-based) of IVD self-testing devices or devices containing human tissue/blood-derived substances imported to Finland
Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
Contrast: Manufacturers, authorised representatives, importers, system/procedure pack producers, and certain custom-made manufacturers must register in EUDAMED. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
3. Notification Timing and Obligations
Notifications must be submitted before manufacturing or making devices available on the market. Keep information updated for changes or terminations. Registration is mandatory under EU regulations and Finnish Medical Devices Act. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
4. Notification Process
E-Submissions (Preferred for Eligible Operators)
Available for:
- Custom-made device manufacturers (non-class III implantable)
- Health institution self-manufacturers
- Obligated distributors
Access via https://cere.easiointi.fimea.fi. Requires strong identification (personal or organisational via Suomi.fi mandates). Guides available in Finnish. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
Forms for Other Operators
Use specific PDF/Excel forms:
- Distributor actor notification (PDF)
- Device notification for imports (Form A, Excel)
- Linked manufacturers for importers (Form E, Excel)
Submit via email or post; Fimea provides reference number within 2 weeks. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
Sterilisation providers: Free-form email to Fimea. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
5. Required Information
Mandatory fields include operator details and, where applicable, device information. For health institutions, one notification covers all self-manufactured devices. No signature required on forms. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
6. Fees
Initial registration fee and annual supervision fees apply per Fimea's decree and Medical Devices Act Section 50. Details on Fimea's fees page. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
7. Practical Notes and Resources
Confirm CERE vs EUDAMED applicability before submitting. Public visibility limited compared to EUDAMED. For e-authorizations help, contact Digital and Population Data Services Agency. Source: Fimea - Device and operator notifications to CERE (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere)
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