EstOnia
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. To put a device on the Estonian market, additional notification is required for Class IIa, IIb, III or AIMD devices, and recommended for Class I and IVD devices.

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.

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 anywhere in the European Union is required.

ADDITIONAL INFORMATION: The Medical Device Directive is due to be changed in 2015.

Last updated on March 17 2015.



ARE YOU INTERESTED IN REGISTRATION 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
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