Device registration

In principle, medical device operators established in Finland are obliged to notify Fimea. However, all obliged distributors who distribute devices to Finland must notify Fimea. Please note that all distributors are not obliged to notify Fimea. 

Operators obliged to notify Fimea:

• The following medical device operators established in Finland
  • a manufacturer
  • an authorised representative
  • an importer
  • sterilisation service provider that sterilises CE-marked medical devices pursuant to the directives before they are put into service. 
    • Units that carry out in-house instrument maintenance at a healthcare unit are not liable to file a notification. However, if such a unit offers its sterilisation services to a manufacturer that places the final product on the market, the service provider concerned shall file a notification with Fimea
  • the manufacturer of a custom-made device
  • self-manufacturer who manufactures medical devices in a health institution in accordance with Article 5(5) of Regulation (EU) 2017/745 that are only used within that health institution established in the Union, or in accordance with sections 27–31 of the Medical Devices Act; 
    • All devices self-manufactured by a health institution are to be included in a single notification (49§)
      • The information for a municipality or an association of municipalities should be submitted with information regarding the municipality (municipalities) as a whole 
      • O 7A private social or healthcare provider shall submit their for each provider that has been registered in the register for private service providers a as stated in 14 § in the Finnish law of Private Healthcare (152/1990)
  • manufacturer of a device for non-medical use to which Annex XVI of the MD Regulation applies (MDR 2017/745, Annex XVI).
• 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

NOTE! The distributor liable to submit a notification to Fimea cannot be an importer or manufacturer. In other words, an actor will not register in many different roles for the same medical device. For example, a manufacturer will not make a distributor’s notification for distributing the device which they manufacture
 

The following medical device operators established in Finland should report their information to the CERE register via e-submissions:   

• manufacturer of custom-made devices, excluding manufacturers of risk class III implantable devices
• self-manufacturer who manufactures medical devices in a health institution
• distributor who makes a medical device available in Finland to retailers, healthcare and social welfare operators and other professional users 
  • Note! Distributors not required to submit device notifications until further notice, more information: Medical device distributors not required to submit device notifications until further notice.

Submit your information to the CERE register using the notification form if you are one of the following actors

• established in Finland:
  • sterilisation service provider 
  • manufacturer of a device for non-medical use to (MDR 2017/745, Annex XVI)
• 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
• distributor situation abroad who makes a medical device available in Finland to retailers, healthcare and social welfare actors and other professional users

Read more: Device and operator notifications to CERE.

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.

Read more: Device and operator notifications to Eudamed.

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 CERE register is a register maintained nationally by Fimea that has replaced Fimea's previous device register. The CERE register meets the requirements laid down in Regulations (EU/2017/745 and EU/2017/746), and operator and equipment data are registered there. CERE registration is usually carried out in e-submissions, but some of the notifications are still submitted to the register using PDF or excel forms. The e-submissions e-service will continue to be developed and expanded in the future. 

The national Medical Devices Act 719/2021 and Fimea Administrative Regulation 2/2021 define which operators, who are subject to the obligation to submit notifications should submit their device and operator data to the CERE register.

Eudamed is a register maintained by the European Commission. In the future, all EU Member States must start using the Eudamed register, but at the moment its use is voluntary in the EU. Regulations (EU/2017/745 and EU/2017/746) define long transitional periods before the use of Eudamed becomes mandatory in all Member States. As a result, Eudamed is not yet in use in all Member States. 

In Finland, the Eudamed register is already in use for domestic operators, so every Finnish medical device manufacturers, importers, authorised representatives, system or procedure pack assemblers or sterilisers as well as manufacturers of custom-made devices (provided that a notified body was used for the device conformity assessment) can be found in the Eudamed register.

In Finland, the national Medical Devices Act 719/2021 and Fimea Administrative Regulation 2/2021 define which medical device operators should report their device and operator information to the Eudamed register. Some medical device operators report their information to the CERE register. 

More information
EUDAMED  (European commission)

Eudamed is a public register maintained by the European Commission. The aim of Eudamed is to offer citizens adequate access to information about medical devices placed on the EU market.

The public register contains the following information:

• 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.

In the future, all EU Member States must start using the Eudamed register, but at the moment its use is voluntary in the EU. Regulations (EU/2017/745 and EU/2017/746) define long transitional periods before the use of Eudamed becomes mandatory in all Member States. As a result, Eudamed is not yet in use in all Member States. 

In Finland, the Eudamed register is already in use for domestic operators, so every Finnish medical device manufacturers, importers, authorised representatives, system or procedure pack assemblers or sterilisers as well as manufacturers of custom-made devices (provided that a notified body was used for the device conformity assessment) can be found in the Eudamed register.

‘Placing on the market’ means the first making available of a device, other than an investigational device, on the Union market.

• Manufacturers and importers are the only operators that place products on the market.
• When a manufacturer or an importer first supplies a device to a distributor or an end user, this is always called, in the legal sense, ‘placing on the market’.
• Placing a product on the market requires an (oral or written) agreement between two or more natural or legal persons to transfer the right of property or possession or other right concerning the product after the manufacturing phase. The transfer can either be made in return for payment or free of charge. It does not require physical handover of the product.

‘Making available on the market’ means any supply of a device, other than an investigational device, for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

• For example, from a distributor to another distributor or from a distributor to an end user.

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.