Medical devices illustration

Registrations

Registrations

Before placing medical devices on the market or making them available on the market, the economic operator shall file a notification with Fimea of its operations and devices. The registration of medical devices shall be carried out in two stages. 

  1. The actor registers either in the Eudamed database or in Fimea’s CERE register, depending on the actor’s role. 
    1. After registration, the supplier will receive an SRN from the Eudamed database or an actor reference number for supplier assigned by Fimea, which the supplier shall use when registering devices.
  2. The actor registers its medical devices related to its operations in the Eudamed database or in Fimea’s CERE register, depending on its role. 

Eudamed or Fimea notification forms shall be used when declaring the information. The forms contain the information that is to be provided in the notifications.

The economic operator liable to file a notification shall keep up to date the data they have declared to Fimea. Any changes to the registered data shall be notified to Fimea without delay.

The submitter shall be

  • authorised to represent the company or trader;
  • an authorised representative of the manufacturer; or
  • any other party responsible for placing the medical device on the market.

Provisions on the obligation to register are laid down in section 49 of the Medical Devices Act (719/2021) and in Chapter III of Regulations EU 2017/745 and EU 2017/746. 

Fimea’s Administrative Regulation 2/2021 specifies in greater detail the information concerning the submission of notifications, the information to be notified, and the procedures related to registration. 

The device module of Eudamed was introduced on the 4th of October, 2021. An actor liable to submit a notification to Eudamed shall, before placing on the market the medical device manufactured, imported, represented or sterilised by the same, notify all the information concerning the device that has been marked as mandatory in the Eudamed-UDI/device module. 

The device information shall be submitted to the Eudamed database no later than within 60 days of the date when the device module of the Eudamed database had been put into service. 

Fimea’s electronic submission service is currently awaiting deployment. After the deployment of the e-submission service, the actor is required check all of its data and update it via the correct system within 60 days at the latest.

Registration of actors

The economic operator liable to submit a notification to Fimea’s CERE register include:

  • manufacturer of custom-made devices, excluding manufacturers of risk class III implantable devices;  
  • 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 
      • A 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)
  • 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.
  • 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;
  • manufacturer of a device for non-medical use to which Annex XVI of the MD Regulation applies (MDR 2017/745, Annex XVI).

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

Actor’s notification form for the CERE register 

Actor’s notification form for actors who are liable to submit a notification to Fimea’s CERE register: Medical device actor’s notification form (pdf)

NOTE! An actor who distributes to retailers, healthcare and social welfare operators and other professional users shall submit an actor’s notification to Fimea's CERE register by 17 December 2021 at the latest.

Other actors liable to file a notification shall submit their actor information to Eudamed: Eudamed actor notification

Registration of devices

An operator liable to submit a notification to Fimea’s CERE register shall, before placing a device on the market, notify the required information concerning the device to Fimea’s CERE register.

Other operators liable to file a notification shall submit their device information to Eudamed: Eudamed notification.

NOTE! An operator who distributes devices to retailers, healthcare and social welfare operators and other professional users shall submit a list of the devices it distributes on an annual basis. The information concerning the devices of the aforementioned distributors shall be up to date by 30 November 2022 at the latest.

Device notification forms  

The distributors’ device notification forms will soon be available in English, the other forms are available only in Finnish.

Fees

The fee for the first registration of a manufacturer, importer, authorised representative, system and procedure pack assembler, sterilisation service provider and manufacturer and self-manufacturer of custom-made devices is €500. The first registration fee is a role-specific one-off charge.

In accordance with section 50 of the Medical Devices Act (719/2021), Fimea charges an operator-specific supervision fee to operators who are liable to file a notification. The supervision fee is determined based on the number of devices notified by the operator as follows:

maximum of 10 devices  €500
11 to 50 devices €1,000
51 to 100 devices €2,000
101 to 500 devices  €4,000
more than 500 devices €6,000

 

The supervision fee will be charged for the first time in 2022. With a few exceptions, the supervisory fee is based on the number of devices reported by the end of 2021.

Importers are charged an annual supervision fee of €500 and manufacturers of sterilisation services are charged an annual supervision fee of €1,000.

The supervisory fee to be charged to distributors liable to file a notification in 2022 is €500, after which the annual inspection fee (from 2023) will be determined according to the number of devices notified to Fimea by the end of the preceding year.