Medical Device Regulations in Finland: Compliance, Registration, and Incident Reporting
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.
https://fimea.fi/en/medical-devices/legislation-related-to-medical-devices
Class I, lla, llb and III
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.
It varies depending upon the class of the device
5 Years
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.
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. Fimea remains responsible for enforcing MDR and IVDR within Finland.
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.
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.
Before placing a medical device into the market.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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