Medical Device Registration and Approval in Estonia
General country-specific regulatory information is provided on this page for medical device registration and approval in Estonia.
Last updated on November 26th, 2021.
Medical Device Regulations and Classification in Estonia
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Estonia, devices are regulated by the Estonian Health Board Terviseamet.
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.
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.
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