MEDICAL DEVICE REGISTRATION AND APPROVAL IN Slovakia

MEDICAL DEVICE REGISTRATION AND APPROVAL IN Slovakia

General country-specific regulatory information is provided on this page for medical device registration and approval in Slovakia
Last update: December 2022

Medical Device Regulations and Classification in Slovakia

REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Slovakia, Devices are regulated by the State Institute for Drug Control (ŠÚKL), Medical Devices Section.

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

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.

LICENSE VALIDITY: 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 is required anywhere in the European Union.

ADDITIONAL INFORMATION: On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace 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. The manufacturer of Class IIa, IIb and III medical devices or its authorized representative shall notify the State Institute, in writing, of data enabling the identification of the manufacturer and the identification of the medical device marketed in the Slovak Republic. The manufacturer of an active implantable medical device, an in vitro diagnostic medical device and a Class I medical device may notify the State Institution, in writing, of the data allowing the identification of that manufacturer and the identification of the medical device marketed in the Slovak Republic.

 

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