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Devices are regulated by the EU list of Competent Authorities. In the Czech Republic devices are regulated by the SUKL - State Institute for Drug Control.
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.
If the manufacturer or authorized representative is established within the territory of the Czech Republic, they must file an application for notification of a medical device placed on the market. This should be filed with the Institute, no later than within 15 days of the date of the placement of the medical device on the market.
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