Device and operator notifications to CERE

Fimea uses e-submissions for the CERE register, but everything cannot yet be managed in the e-service. Some of the notifications must still submitted to the register using PDF or excel forms. Before submitting the notification, check the section "Where do I report my information; to the CERE or EUDAMED register?", see if you can you submit the notification in e-submissions or should you use forms to submit the notification to CERE or EUDAMED?

E-submissions for medical devices is intended for:

• the self-manufacturers of social welfare and health care units
• the manufacturer of a custom-made device, excluding manufacturers of risk class III implantable devices 
• distributors who are obligated to submit a notification.

Other operators subject to an obligation to report information on medical devices will submit a notification to Fimea either via EUDAMED or using the notification forms available on Fimea's website.

In e-submissions, you can:

• report your operator and device information
• manage your reported data (submit notifications of changes and terminations)
• browse your registered data.

Use of e´-services requires a Finnish personal identity code and identification tokens, which include

• online banking codes
• mobile certificate 
• an identity card with a chip that enables online transactions.

 
In order to act on behalf of an organisation/company, you must also have the necessary rights given to you by your organisation/company.  

You do not need a separate Suomi.fi mandate for Fimea’s e-submissions if you are acting on behalf of a company/organisation in which you have an official role entered in the Trade Register: 

• managing director and their deputy 
• liquidator 
• trader (it is enough that they are a entered in the BIS) 
• responsible partner 
• holder of procuration (authorised to sign alone)

If you do not work in the organisation/company in the above-mentioned roles, you must request a mandate for transactions in the Suomi.fi service and the organisation/company must grant it to you. The name of the mandate for e-submissions for medical devices in the Suomi.fi e-Authorizations service is "Management of information related to medical devices". Read more about granting mandates in the instructions Acting on behalf of an organisation: Authorisation (pdf) and mandates granted by organisations in Suomi.fi.

Quick guide for e-services (in Finnish) (pdf)
Log in to the e-submissions of medical devicesWe recommend using modern, updated browsers.

Note! Due to the application update, there may be a service interruption on Wednesdays between 10am and 11am. We apologise for any inconvenience caused by the downtime.

Instructions for using e-services

Acting on behalf of an organisation: Authorisation (pdf)
Instructions for e-submissions for medical devices - operator and device (in Finnish)

Advice on e-submissions

[email protected] 
Do you need help with Suomi.fi. e-Authorizations? Help is available from Public Service Info https://www.kansalaisneuvonta.fi/en-US.

Fimea uses e-submissions for the CERE register, but everything cannot yet be managed in the e-service. Some of the notifications must still submitted to the register using PDF or excel forms. Before submitting the notification, check the section "Where do I report my information; to the CERE or EUDAMED register?", see if you can you submit the notification in e-submissions or should you use forms to submit the notification to CERE or EUDAMED?

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 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)
• distributor who makes a medical device available in Finland to retailers, healthcare and social welfare operators and other professional users

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.

An operator subject to an obligation to submit a notification to Fimea’s CERE register shall, before the manufacture of a device, submit the required information concerning the device to Fimea’s CERE register. With the help of e-submissions, you can also ensure your information is up to date, i.e. submit notifications of changes and termination of operations and view the information reported to CERE.
Log into e-submissions through Suomi.fi e-Identification. Read more in the section "E-submissions" and read the instructions Acting on behalf of an organisation: Authorisation (pdf).

Quick guide for e-services (in Finnish) (pdf)
Log in to the e-submissions of medical devicesWe recommend using modern, updated browsers.

Note! Due to the application update, there may be a service interruption on Wednesdays between 10am and 11am. We apologise for any inconvenience caused by the downtime.

Instructions for using e-services

Acting on behalf of an organisation: Authorisation (pdf)
Instructions for e-submissions for medical devices - operator and device (in Finnish)

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 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
  • 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 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

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.

An operator subject to an obligation to submit a notification to Fimea’s CERE register shall, before the manufacture of a device, submit the required information concerning the device to Fimea’s CERE register. Use the notification forms to keep the information up to date, i.e. for notifying of changes and ceasing of operations. 

Notification forms  

• an operator notification to a 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 and a foreign distributor who makes a medical device available in Finland to retailers, healthcare and social welfare operators and other professional users
  • distributor's, medical device actor’s notification form (pdf)
• device notification forms for operators
  • Device notification form for a distributor if the device is an IVD device intended for self-testing or a device containing substances of human origin
    • Distributor’s device information notification form (import to Finland) - Form A (Excel)
  • A form for importers according to the MD and IVD Regulations as well as the IVD Directive about the manufacturers of the medical devices which they import
    • Importer's Linked Manufacturers – Form E (Excel) (only in Finnish or Swedish)
    • The information is linked in the Eudamed Actor module. If the manufacturer has yet to register themselves in Eudamed, the linking is done by notifying Fimea using an Excel form
  • Sterilisation service providers
    • Report operations by sending a free-form notification to: [email protected]. 

How to fill and submit the form

1. Complete all mandatory fields of the form. 
2. Read the instructions carefully if you have any problems.
3. You do not need to sign the form
4. Send the completed form to Fimea at: [email protected] 
5. Within 2 weeks, Fimea emails an operator reference number to the operator who send the notification. 

Alternatively, you can send the form by post.

Fimea uses e-submissions for the CERE register, but everything cannot yet be managed in the e-service. Some of the notifications must still submitted to the register using PDF or excel forms. Before submitting the notification, check the section "Where do I report my information; to the CERE or EUDAMED register?", see if you can you submit the notification in e-submissions or should you use forms to submit the notification to CERE or EUDAMED?

How to access e-submissions:

• Go to https://cere.easiointi.fimea.fi. 
• You will be directed directly to the Suomi.fi e-Identification service. 
• Once in the Suomi.fi e-Identification service, you can select the desired identification method. Identification takes place with online banking codes, a certificate card or a mobile certificate. After identification, select the "Continue to the service" button to access the front page of e-submissions for medical devices. 
• The correct e-service has a blue button "use service as a company", which allows you to identify yourself as a company. 
  • Please note that you must have the right to act as part of your official role or you must have requested and been granted a mandate for transactions from the company before using the service.
• After this, you will be redirected to the Suomi.fi e-Identification service, where you will select which company you are acting on behalf of. After the selection, press the blue button "select and go to the e-service", in which case you will be directed to the selection of your role in the e-service.

After you have identified yourself, check that you are acting on behalf of the correct company.

Instructions for using e-services

Acting on behalf of an organisation: Authorisation (pdf)
Instructions for e-submissions for medical devices - operator and device (in Finnish)

When registering medical device operators and devices, acting on behalf of an organisation will require that you have the necessary rights to act on behalf of your organisation.  When someone is given a mandate, this means that they now have or have been granted the right to act on behalf of a company, association or other organisation. Fimea's e-service will receive information from the Suomi.fi e-Authorizations service on whether the person has the right to act on behalf of the organisation. 

The information is checked in the Trade Register, the Business Information System, the Register of Associations and Suomi.fi e-Authorizations.  

You do not need a separate Suomi.fi mandate for Fimea’s e-submissions if you are acting on behalf of a company/organisation in which you have an official role entered in the Trade Register: 

• managing director and their deputy 
• liquidator 
• trader (it is enough that they are a entered in the BIS) 
• responsible partner 
• holder of procuration (authorised to sign alone)

If you do not act in the company's aforementioned roles, you must request a mandate for transactions in the Suomi.fi service to act on behalf of the organisation in Fimea's register for medical device operators and devices. 

Granting a mandate in the Suomi.fi service

Most organisations can authorise the persons of their choice to act on behalf of their organisation. In the service, a mandate is granted by a person who has the right to sign for the organisation or by a person who has been granted a separate right to grant mandates. A mandate for transactions can be granted to one or more persons at the same time.

Do the following to grant a mandate for acting on behalf of a company

If you need the assistance of an official for granting a mandate, first submit a mandate application in Suomi.fi. Read the instructions first and then complete the application. Once the mandate has been approved, start in accordance with section 1 by opening the Suomi.fi e-Authorizations home page. 

1.  Open the Suomi.fi e-Authorizations home page.
2.  Identify yourself in Suomi.fi e-Authorizations.
3.  Click Change user role on the right side of the page.
4.  Select Act on behalf of the company from the menu that opens.
5.  From the list, select the company or organisation on whose behalf you are acting.
6.  Select Confirm and continue to the e-service.
7.  After confirming, click the Add new mandate button on the right side of the page.
8.  Select Grant a mandate.
9.  Select Mandate for transactions as the mandate type.
10.  After navigating to the next page, click Add person.
11.  Enter the name and personal identity code of the assignee.
12.  Select the validity period of the mandate.
13.  From the list that opens to the left, select Management of information related to medical devices.
14.  Check that the information that you entered is correct and select Validate the mandate.
15.  You will be notified of the mandate validation.

If you are a private client and having problems managing Suomi.fi e-Authorizations, contact the Public Service Info: https://www.kansalaisneuvonta.fi/en-US.

If you are a corporate client and having problems managing Suomi.fi e-Authorizations, please contact the Digital and Population Data Services Agency's customer service for organisations:
https://dvv.fi/en/customer-service-for-organisations.

Read more

Acting on behalf of an organisation: Authorisation (pdf)
Granting mandates as an organisation

You can log in to the e-submissions for medical devices using Suomi.fi e-Identification.

E-services work with the most commonly used, updated web browsers, such as Google Chrome, Mozilla Firefox, Microsoft Edge and Safari. If you cannot access e-Identification, clear your browser's cache and then try logging in again.

If the problem occurs during the identification phase, the fault may be in the Suomi.fi service or the means of identification you are using. You can try the following methods:

• Log in using another means of identification.
• Try logging in to a different service that uses the Suomi.fi service (e.g. MyTax).
• Try logging into the e-service with a different browser.
• There may be an update interruption in electronic services, in which case the service is not available. Try again in a moment.

Suomi.fi provides advice to the public on identification: Public Service Info: tel. +358 29 5000 (Mon–Fri 8am–9pm, Sat 9am–3pm). For more information see Public Service Info.

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)

A custom-made device refers in Regulation 2017/745 to a device intended for the sole use of a particular patient exclusively to meet their individual conditions and needs, which was manufactured with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics. Custom-made medical devices include dentures and other dental technician work, as well as certain optical devices, hearing aids and aids such as prostheses and orthoses.

Read more about the risk classification and registration of a custom-made device.

Self-manufacturing is limited to situations where the specific needs of the target patient group cannot be met by a similar device available on the market or where the performance of the available device is insufficient for the specific needs of the patient group. Devices manufactured by a health care unit themselves may not be distributed outside the health care unit. In addition, the health care unit shall make publicly available a declaration stating the compliance of the self-manufactured device with the essential safety and performance requirements (2017/745, 2017/746 Annex I). 

Read more about self-manufacturing.

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.