Finland Medical Device Registration

Medical Device Regulations in Finland: Compliance, Registration, and Incident Reporting

Updated on 26/01/24

Regulatory Authority: National Supervisory Authority for Welfare and Health (Valvira)

Fimea supervises the compliance of medical devices and operators in the field in Finland. The control of device conformity concerns medical devices placed on the market and their professional use and maintenance. Supervision takes place in cooperation with other EU authorities.

In addition, Fimea supervises the marketing of medical devices and processes emergency notifications, as well as grants accessibility certificates for medical devices, research and exemption permits.

Link for Regulatory Authority: https://www.fimea.fi/

Local Regulation:

• Medical Devices Act 719/2021
• Medical Device Regulation (EU) 2017/745

https://fimea.fi/en/medical-devices/legislation-related-to-medical-devices

Classification:Class I, lla, llb and III

Listing or Registration Requirements:

• The reporting entity must inform Fimea of its operations and devices before they are sold, put on the market, or made available.
• Registration is mandatory for all classes for manufacturers and AR in Finland.
• All medical devices eligible to be marketed in Finland must conform with existing EU regulations and be safe to use. Manufacturers are obliged to prove the performance and reliability of their medical devices, and their suitability for intended use. If all these conditions are met, the device is provided with a CE marking – proof of conformity with EU MDR and IVDR regulations.
  • The actor registers either in the EUDAMED database or in Fimea’s CERE register, depending on the actor’s role. 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.
  • The actor registers its medical devices related to its operations in the EUDAMED database or in Fimea’s CERE register, depending on its

Documents Required: Contact details and product information; The actor registers either in the EUDAMED database or in Fimea’s CERE register, depending on the actor’s role.

Registration Timeline:It varies depending upon the class of the device

• For Class I medical devices it is the quickest and takes on average from 4 to 6 weeks.

Registration Fee:

• The fee for the first registration of a manufacturer, importer, authorized representative, system and procedure pack assembler, sterilization service provider and manufacturer and self-manufacturer of custom-made devices is €500. The first registration fee is a role-specific one-off charge.
• Importers are charged an annual supervision fee of €500, and manufacturers of sterilization 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.

License Validity:5 Years

Special Labelling Requirements:The information and documents referred to in Article 10(11) of the MD Regulation and Article 10(10) of the IVD Regulation shall be in Finnish, Swedish or English.

Additional Comments: Finland’s medical device regulations are governed by the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). These regulations replaced previous directives and took full effect in 2020 (MDR) and 2022 (IVDR). Manufacturers must notify contact details and product information to the Eudamed database for all devices placed on the market after these dates. High-risk devices require additional notification within two weeks of meeting conformity requirements, submitting for evaluation, or starting import of self-testing IVDs. While Finland’s National Supervisory Authority for Welfare and Health (Fimea) used to maintain a product register, it is now the central Eudamed database that provides EU-wide transparency. Fimearemains responsible for enforcing MDR and IVDR within Finland.

Incident Reporting:

In addition to managing registrations and overseeing compliance, Valvira serves as the designated authority for reporting adverse incidents. Any serious incidents must be promptly reported within ten days of occurrence, while cases of near incidents should be reported within 30 days.

If the incident is attributed to a medical device manufactured in Finland and occurs in any other European Economic Area (EEA) State aside from Finland, the report should be directed to the regulatory authority of the specific State where the incident took place.

Language Requirements:

As outlined in the Medical Devices Act 629/2010 (available only in Finnish), it is mandatory for all medical devices to bear markings and instructions that guarantee their safe use. Manufacturers are obligated to include their contact information on the device or its packaging.

All markings and instructions must be presented in both Finnish and Swedish. For information intended for patients or users, the requirement is to provide it in either Finnish or Swedish. Instructions and all other details concerning the medical device can be furnished in Finnish, Swedish, or English.

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]