REGULATORY AUTHORITY: 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.
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.
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. This obligation shall apply to the authorized representative established within the territory of the Czech Republic also in cases when the medical device is placed on the market by another person. This obligation shall not apply to custom-made medical devices.
