825 08 Bratislava 26
RAPID ALERT SYSTEM
TEL: +421 903 251 979
FAX: +421 2 5556 0022
1€ = 30,1260 Sk
State Institute for Drug Control (SIDC), Medical Devices Section, performs the function of the Competent authority for medical devices in Slovakia.
According to the Slovak law, any Slovak manufacturer, or authorized representative, who under his own name places medical devices (all types: MDs, IVDs, AIMDs) on the market shall inform SIDC about the address of the registered office and shall descript the devices concerned ( Act No.362/2011 Coll., § 110 sect.2 and 3).
Any other manufacturer of medical devicess 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 SIDC about himsef and devices concerned (Act No.362/2011 Coll., § 110 sect. 4)
Notifier is an authorized person (mostly the distributor), who on behalf of the manufacturer performs the registration/notification in SIDC.
Registration/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,-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 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,-label of medical device in Slovak language. Symbols are acceptable,-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.2AIMD Regulation No.527/2008 Coll., § 3 sect.2IVD Regulation No.569/2001 Coll., § 2 sect.2
When all the documentation is complete, SIDC will generate the code(s) as soon as possible, 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 registration/notification of medical devices class I non-sterile, class I non-measuring and IVD-others is permanent. The validity of registration/notification of all other types of medical devices depends on the validity of CE-certificate.
SIDC issues one type of output:"Output of code database" for all medical devices