Manufacturers domiciled in Finland shall notify their contact details and information on the products they manufacture for the product register maintained by the Finnish Medicines Agency Fimea 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 authorised representative established in Finland is required to submit a similar notification.
Manufacturers are obliged to notify of devices deemed to be high-risk, including IVDs intended for self-testing and devices containing substances of human origin.
The party submitting the notification shall be
- entitled to represent the company or entrepreneur
- an authorized manufacturer’s representative, or
- another party responsible for placing the medical device on the market
Notifications concerning IVDs and the manufacture of medical devices shall be submitted on the designated form.
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.