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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.
Medical devices are classified according to risk into Classes I, IIa, IIb and III.
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.
Licenses issued in the EU are valid for five years.
An authorized representative is required anywhere in the European Union.
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.
Prior to bringing a medical device which may cause a severe health risk into trade in Finland, the manufacturer or an authorized agent (having a registered office in Finland) and the importer of the device must file a notification with the MOH.
Last updated on October 19, 2018.
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For more information on registration in the EU, check out the following articles on our blog:
5 Questions and Answers: Additional Regulations in the EU
4 Steps to Comply With EU Directive RoHS 2