Devices are regulated by the Medical Devices Section, under the State Institute for Drug Control (SIDC). Medical devices must have a CE Mark to be sold in Slovakia. CLASSIFICATION SYSTEM:
Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV. TIMEFRAME:
The EU 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. Licenses for certain Class I and IVD devices do not expire in Slovakia. 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.
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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