Notification procedure of medical devices in Slovakia

Notification procedure of the manufacturer and medical devices in Slovakia

State Institute for Drug Control (ŠÚKL), Medical Devices Section, performs the function of the Competent authority for medical devices in Slovakia.

The manufacturer of medical devices class IIa, IIb and III, or authorized representative, who under his own name places medical devices on the market and/or puts them into service in Slovakia must notify ŠÚKL about himsef and devices concerned (Act No.362/2011 Coll., § 110 sect. 4).

Notifier can be manufacturer, authorized representative, distributor or other person, who (on behalf of the manufacturer) performs the notification of the manufacturer and devices in ŠÚKL.

Notification of medical devices in Slovakia is cost-free.

The requirements for successful and efficient notification are standard:
-correctly 2x filled in Notification form in Slovak language,
-letter of attorney to act on behalf of the manufacturer,
-EC Declaration of Conformity issued by manufacturer (can be in English),
-copy of valid certificate issued according to the conformity assessment procedures (can be in English),
-instructions for use (IFU) in Slovak language both for public and for professionals, SW interface can be in English language, but displayed text must be clarified in Slovak language (e.g.in IFU),
-label of medical device in Slovak language, symbols are acceptable (EN 980, EN ISO 15223-1),
-technical documentation - in the case of borderline product, or in the case of doubts, that the product meets the definition of medical device.

The language requirements you can find in MD Regulation No.582/2008 Coll., § 3 sect.2.

When all the documentation is complete, ŠÚKL will generate the code(s), which is (are) needed for further communication with the Slovak health insurance companies, pharmacies, supply points for medical devices and the Ministry of Health of Slovakia.

The validity of notification of class IIa, IIb and III medical devices depends on the validity of CE-certificate.

Print page
eu-flag.png sk-flag.png