General country-specific regulatory information is provided on this page. Become a LICENSALE.COM
user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.
Devices are regulated by the EU list of Competent Authorities. In Estonia, devices are regulated by the Estonian Health Board Terviseamet.
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.
A medical device placed on the market or put into use in the European Union is allowed to be sold in Estonia, although there is a requirement for notification if the device is in Class IIa, IIb, III or AIMD (§ 26 of Medical Device Act); the notification of Class I devices and in vitro diagnostic medical devices is also recommended.
Last updated on October 19, 2018.
Interested in obtaining fast market approval for your medical device or IVD in the EU? REQUEST A FREE QUOTE>
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