In Slovakia large part of local legislation is impacted by European Union legislation, as the country is part of the committee. Registration as well as translation of medical devices has its exact rules, which has to be followed.
How to start?
In general in the first phase manufacturer or authorized representative has to prepare the dossier of Medical device. One of the crucial part is the technical documentation. The manufacturer or authorized representative must have a technical documentation demonstrating the conformity of his products with the requirements of Directive 93/42 / EEC.
This technical dossier must be prepared before the EC Declaration of Conformity is drawn up to be made available to the competent authority in the SR – SIDC (Slovak Institute for Drug Control).
Manufacturers should check the language requirements of the competent authority. The technical documentation should be prepared from an overview of the essential requirements and other relevant requirements of the Directive and include for example: Description of the MD, raw materials, specifications, final product documentation, or packaging and labeling documentation, etc.
Specific requirement of the market
Even though the core documentation and certificates can be submitted in English some parts of the documentation must be submitted in Slovak. It concerns for example labeling, product information leaflet, cover letter.
Another special requirement of Slovak market is the manufacturer or authorized representative has to have a local contact person.
What requirements has local contact person meet? Has to have residency in Slovak republic, has to communicate in Slovak, has to obtain Power of attorney from manufacturer or authorized representative and is responsible for contact between SICD and manufacturer in case of need.
In terms of Slovak language requirements a general rule is to meet the strict criteria of wording same as for drugs. And some specific rules has to be applied for translation.
Example: Patient should use the medical device…
Normal usual translation to Slovak is: Pacient by mal používať zdravotnícku pomôcku
But proper translation for MD labeling and PIL requirements is: Pacient má používať zdravotnícku pomôcku
The procedure is complex and needs to have a specialist with knowledge of the domain, as well as knowledge of the method of translation from English to Slovak, as well as the local presence.
If you need more information do not hesitate to contact us via regimed@regimed.sk or visit our website www.regimed.sk
Author: Veronika Hlivová