National registration is required in Slovakia. As a non-EU manufacturer of medical devices, you are required to use a European (legal) representative to register your medical device with the Slovak database. Non-Slovak manufacturers that are based in European Union are also required to complete this registration themselves or appoint a legally-mandated representative to register for them.
Slovak legislation indeed requires the manufacturer of medical devices class IIa, IIb and III, or authorized representative, who under their own name place medical devices on the market and/or puts them into service in Slovakia to notify State Institute for Drug Control (ŠÚKL), that performs the function of the Competent authority for medical devices in Slovakia according to Act No.362/2011 Coll., § 110 sect. 4.
Notification of medical devices in Slovakia only requires a small payment for the creation of the Registration Code.
There are a few requirements for successful and efficient notification:
-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 validity of notification of class IIa, IIb and III medical devices depends on the validity of CE-certificate. Language requirements can be found in MD Regulation No.582/2008 Coll., § 3 sect.2.
Once all the documentation is submitted, ŠÚKL will generate the codes, which are needed for further communication with the Slovak health insurance companies, pharmacies, supply points for medical devices and the Ministry of Health of Slovakia.
Third party commercial entities, like distributors, should not register your medical devices for several reasons, a few of which are:
1.By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his medical device in Slovakia.
2.If you decided to end the relationship with your commercial distributor at any point, you would be required to take your medical device completely off the market until you could re-register that medical device within Slovakia for a second (third, fourth, etc.) time
3.Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device.
1.For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs
2.The manufacturer should register their medical devices with the Slovakian database through his appointed Authorized Representative
Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France, Greece, Latvia, Bulgaria and Croatia) and strengthen the need for a professional European Authorized Representative present at any time.