Registration of medical devices in Slovakia

Registration of medical devices in Slovakia

Placing your medical device into the European market is contingent  upon your compliance with the Medical Device Directive (93/42/EEC).  While this Directive is a law to all 28 member states within the  European Union, each member state has its own way of implementing the  Directive within their country, essentially adding regulations to the  Directive and creating Local Legislation.An  example of such local implementation of the Directive is now present 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.

Conclusion:

  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

If you wish to register your device in Slovakia, you can contact us to Get a Quote.

Francesca Zuccarello Cimino

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