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February 10, 2026
Approximately 5 minutes
EUDAMED Registration Requirements for Medical Device Operators and Devices in Finland
EUDAMED Registration Requirements for Medical Device Operators and Devices in Finland
1. Overview of EUDAMED and Finnish Obligations
The European Database on Medical Devices (EUDAMED) enhances transparency and traceability of medical devices in the EU market, established under MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746). In Finland, Fimea oversees registrations, with some operators using the national CERE register and others required to use EUDAMED directly. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
For registration questions, contact Fimea at [email protected]. For technical issues in EUDAMED, contact [email protected]. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
2. Actor Registration: EUDAMED vs. CERE
Operators Required to Register in EUDAMED
Finnish-established operators must register in EUDAMED if they are:
- Manufacturers
- Authorised representatives
- Importers
- System or procedure pack producers (including sterilisers)
- Manufacturers of custom-made devices where a notified body was involved in conformity assessment (including class III implantable)
This includes 'legacy actors' under transitional provisions (Article 120 MDR and Article 110 IVDR). Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
Operators Required to Register in CERE
Certain operators register via Finland's national CERE system, including:
- Manufacturers of custom-made devices (except class III implantable with notified body)
- Health institutions manufacturing devices (self-manufacturers)
- Distributors making devices available to professional users (temporary exemptions may apply)
- Sterilisation service providers
- Manufacturers of non-medical devices under MDR Annex XVI
- Specific distributors of self-testing IVDs or devices with human-derived substances
Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
Operators must submit all mandatory information in EUDAMED and keep data updated, notifying material changes immediately. Importers must link to manufacturers (using a specific Excel form if manufacturer not yet registered). Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
Login to EUDAMED: https://webgate.ec.europa.eu/eudamed/landing-page#/
Key resources:
- Fimea instructions for actor module (PDF)
- European Commission EUDAMED user guides and FAQs
Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
3. Device Registration in EUDAMED
Device information must be registered in EUDAMED by:
- Manufacturers
- Importers
- System/procedure pack producers
Before placing devices on the market, operators must submit all mandatory UDI/Device data. Importers link devices to manufacturers. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
Resources include Fimea guidance (in Finnish) and Commission user guides for UDI and legacy devices. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
4. Key Concepts: SRN, UDI, and EMDN
Single Registration Number (SRN)
Issued after national authority approval of actor registration request in EUDAMED. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
Unique Device Identification (UDI)
Mandatory for traceability; assigned by manufacturer using issuing agencies (e.g., GS1 in Finland). Required in EUDAMED but not in CERE. Transitional periods apply for labelling. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
European Medical Device Nomenclature (EMDN)
Mandatory in EUDAMED for device classification; voluntary in CERE. Available free at European Commission site. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
5. EUDAMED Modules and Status
EUDAMED includes six modules: Actor, UDI/Devices, Notified Bodies/Certificates, Clinical Investigations, Vigilance, Market Surveillance. Actor, UDI/Devices, and Notified Bodies modules are currently in use. Full functionality pending. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
6. Fees and Practical Notes
Registrations incur initial and annual supervision fees per Finnish decree and Medical Devices Act. Registration is mandatory, not voluntary. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
Public visibility: Not all Finnish operators/devices appear in public EUDAMED due to transitional rules and national registrations. Source: Fimea - Device and operator notifications to Eudamed (https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-eudamed)
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