REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Finland, devices are regulated by the Finnish National Supervisory Authority for Welfare and Health, Valvira.
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
Manufacturers domiciled in Finland shall notify their contact details and information on the products they manufacture for the product register maintained by the National Supervisory Authority of Welfare and Health if the manufacturer.
1) In its own name places medical devices on the market.
2) Puts together systems and procedure packs to form medical devices for the purpose of placing these on the market in its own name.
3) Sterilizes systems, procedure packs or medical devices bearing a CE marking.
An authorized representative established in Finland is required to submit a similar notification.
Manufacturers are obliged to notify all devices deemed to be high-risk, including IVD’s intended for self-testing and devices containing substances of human origin.
Notification shall be submitted within two weeks of the device and its conformity procedures meeting legal requirements and the placement of the device on the market, or when the device has been submitted for performance evaluation.
Notification of the import of a self-testing device shall be made within two weeks of the start of importing.