Device and operator notifications to Eudamed

The following medical device operators established in Finland should notify their information to the CERE register:    

• manufacturer of custom-made devices, excluding manufacturers of risk class III implantable devices
• self-manufacturer who manufactures medical devices in a health institution 
• sterilisation service provider 
• manufacturer of a device for non-medical use to (MDR 2017/745, Annex XVI)

The following medical device operators should notify their information to the CERE register: 

• distributor who makes a medical device available in Finland to retailers, healthcare and social welfare operators and other professional users
• distributor who makes available on the market an IVD device for self-testing or a device that contains human tissue or substances derived from human blood or plasma they have imported to Finland

The following medical device operators established in Finland should notify their information to the EUDAMED register: 

• a manufacturer
• an authorised representative
• an importer,
• a system or procedure pack assembler, or steriliser thereof
• the manufacturer of a custom-made device, if a notified body has been used in the conformity assessment of the device.

Note! The obligation to submit a notification to EUDAMED also pertains to the ‘legacy actors’ under Article 120 of Regulation 2017/745 and Aricle 110 of Regulation 2017/746.

The following medical device operators established in Finland should notify their information to the EUDAMED register: 

• a manufacturer
• an authorised representative
• an importer
• a system or procedure pack assembler, or steriliser thereof
• the manufacturer of a custom-made device, if a notified body has been used in the conformity assessment of the device

Note! The obligation to submit a notification to EUDAMED also pertains to the ‘legacy actors’ under Article 120 of Regulation 2017/745 and Aricle 110 of Regulation 2017/746.

The economic operator shall state all the information defined as mandatory in the EUDAMED database.

Importers are to link themselves to the manufacturer whose medical devices they import (If the manufacturer has yet to register themselves in EUDAMED, the linking is done by notifying Fimea using an Excel form: Importer’s Linked Manufacturers - Form E (Excel) (only in Finnish)).

The operators liable to file a notification shall keep up to date the data they have declared to Fimea. Fimea must be immediately notified of any material changes to the registered information through EUDAMED.

Log into EUDAMED 

Documents and instructions:

Fimea’s instructions for submitting a notification to the actor module (pdf)
EUDAMED Information Centre (European Commission)
EUDAMED user guide Economic Operator – Actor module (European Commission)
EUDAMED Mandate Summary document that a non-EU manufacturer should provide in its Actor registration request (European Commission)

More information
ACTOR MODULE FAQs (European Commission)
Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR, MDCG 2021-13 (European Commission)
Actor registration module (European Commission)

The following medical device operators established in Finland should notify their device information to the EUDAMED register: 

• a manufacturer
• an importer
• a system or procedure pack assembler, or steriliser thereof

Before placing a medical device it has manufactured, sterilised or represents on the market, an operator established in Finland and obliged to submit a notification to EUDAMED must notify all the information concerning the device that has been marked as mandatory in the EUDAMED UDI/device module.

Note. Importers are to link themselves to the manufacturer whose medical devices they import. If the manufacturer has yet to register themselves in Eudamed, the linking is done by notifying Fimea using an Excel form: Importer’s Linked Manufacturers - Form E (Excel, onlu in Finnish). The information is linked in the EUDAMED Actor module.

The operators liable to file a notification shall keep up to date the data they have declared to Fimea. Fimea must be immediately notified of any material changes to the registered information through EUDAMED.

Log into EUDAMED 

Documents and instructions:

Fimean ohje talouden toimijoille EUDAMEDin laiterekisteröintiin (pdf, only in Finnish)
EUDAMED Information Centre (European Commission)
Legacy Devices (Komission käyttöohje UDI/laiteosioon) (European Commission)
UDI Devices (Komission käyttöohje UDI/laiteosioon) (European Commission)

More information

MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 
UDI/Devices registration (European Commission)

EUDAMED is an IT system developed by the European Commission, established based on Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

The database is structured around 6 interconnected modules and a public website:

• Actor registration (manufacturers, authorised representatives and importers)
• UDI/devices registration
• Notified bodies and certificates
• Clinical investigations and performance studies
• Vigilance and post-market surveillance
• Market surveillance

EUDAMED will be deployed in stages. The actor registration module, UDI/ device registration module, and the notified bodies and certificates module are in use.

Actor module

In the Actor module, operators submit a registration request including information required to issue an Actor ID or Single Registration Number (SRN). Next, a national authority reviews and approves the request and EUDAMED creates an Actor ID/SRN for the operator and notifies the operator who made the request. 

Infographics:
Basic UDI-DI and UDI-DI concept
Registration process

UDI/device module

The EU device identification system was enabled in the Regulations. The device identification system is based on a unique device identifier (UDI) allowing easier traceability and identification of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. UDIs will be added to labels in stages but will be completed by 2027, depending on the risk class of the device.

Infographics:
Basic UDI-DI and UDI-DI concept
Registration process

Log into EUDAMEDPublic EUDAMED

More information:

EUDAMED (European Commission)
Unique Device Identifier (UDI) (European Commission)
Unique Device Identification (UDI) System (European Commission)

EMDN is European Medical Device Nomenclature defined in Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The nomenclature is included in the EUDAMED register and it aims at supporting the functioning of EUDAMED. Using the nomenclature is mandatory in EUDAMED which is why Fimea uses it in the registration of medical devices. In the CERE register, use of the nomenclature is voluntary.

The primary aim of the nomenclature is to serve regulatory purposes to support MDR and IVDR requirements, but it also supports all actors and provides key descriptions of medical devices available on the market. As the nomenclature is available free of charge to all actors, it can be used by manufacturers, patients, research organisations, hospitals, pharmacies, etc. The nomenclature is available in English, but translations will be prepared.

You can review and download the EMDN nomenclature in PDF and Excel format at:
webgate.ec.europa.eu/dyna2/emdn 

More information:
Questions & Answers: European Medical Device Nomenclature (EMDN)

Unique Device Identification (UDI) is a unique numeric or alphanumeric code specific to a medical device. It allows for unequivocal identification of certain devices on the market, facilitates their traceability and provides useful information about devices. The specificity of the UDI:

• makes traceability of devices more efficient
• allows easier recall of devices
• combats counterfeiting
• improves patient safety.

The UDI will be an addition to, not a substitute for, the existing labelling requirements for medical devices.

According to the Regulations, the manufacturer of the device must assign an UDI to the device and to all higher levels of packaging before placing the device on the market. Transitional periods still apply for placing a UDI on labels. In addition to the UDI, the manufacturer must also assign a basic UDI-DI.  The code allows searching the EUDAMED for device-specific information. 

The Commission has designated four organisations as Unique Device Identification (UDI) issuing agencies which issue UDIs to manufacturers. One of the issuing agencies, GS1, is located in Finland. The other issuing agencies are: HIBCC, ICCBBA and IFA.

The use of UDIs is mandatory in EUDAMED, but UDI is not required for operators who register to the CERE register.

More information:
Unique Device Identifier (UDI) European Commission)
Unique Device Identification (UDI) System (European Commission)
UDI Helpdesk (European Commission)

According to the Regulations, the European Commission cannot require the use of the Actor module or the UDI/Device module before EUDAMED is fully functional. The Regulations also define transitional periods for the adaptation of EUDAMED in all EU Member States. These transitional periods start from the date when EUDAMED becomes fully functional. According to the Regulation, fully functional means that all modules of Eudamed are in use.

However, the transition rules defined in the Regulation allow authorities to decide at Member State level on registrations before EUDAMED is fully functional. In Finland, operators and devices are registered to the EUDAMED or CERE register.

EUDAMED contains Finnish medical device manufacturers, importers, authorised representatives, system or procedure pack assemblers or sterilisers and manufacturers of custom-made devices (if a notified body has been used in the conformity assessment of the device). The rest of the operators, such as distributors, are in the CERE register. 

Registration of medical device operators and devices is subject to the first registration fee for an operator and annual supervision fees. Registration fees are based on the current Decree on fees chargeable by the Finnish Medicines Agency and the national Medical Devices Act 719/2021 (Section 50). 

Registering with Fimea is not voluntary. The registration obligation is based on national law and EU Regulations. 

More information about fees can be found on the “Fees” page.