Due to the enormous increase in the number of submitted applications and the extension of processing times, the ZP Section recommends:
Not to submit a notice of ZP, which is not subject to the notification obligation pursuant to Act 362/2011, §110 b, par. 2, i.e. not to submit a notification on the availability of Class I medical devices and Class A in vitro diagnostic medical devices, except in cases of inclusion in the categorization at the Ministry of the Ministry of the Interior.
Not submitting a notification on the fulfillment of all conditions according to Article 120MDR of the transitional period in relation to Regulation (EU) 2023/607 for medical devices and according to Article 110 IVDR of the transitional period in relation to Regulation2024/1860 for in vitro diagnostic medical devices (hereinafter ” regulations “). j. it is not necessary to submit change reports to ŠUKL , in which only an extension is carried out in the sense of the transition period according to the regulations, without any other relevant change at the same time (e.g. change of manufacturer, change of address of manufacturer, change of EC REPa, extension of ŠUKL code, change of class or name ZP and so on).
In such a case, documents confirming the fulfillment of the conditions of the transitional period must be submitted only at the request of ŠÚKL .
Warning: In case of finding that the ZP placed on the market in the Slovak Republic does not meet all the conditions of the transitional period in relation to the regulations, the ŠÚKL may, in accordance with § 110b par. 5 of Act no. 362/2011 Coll. on medicines and ZP to order the withdrawal of medical 1. 2.
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devices and in vitro diagnostic medical devices from the market of the Slovak Republic or from use until the manufacturer, authorized representative, importer or distributor begins to cooperate or provides complete and correct information.
The validity of certificates issued by NB will not be temporarily displayed in the publicly available database due to the transitional periods according to the regulations.
The absence of a validity date in the ŠÚKL search database in no way means that the validity of these certificates is unlimited or that they are invalid. The certificate is valid until the date specified in it or until the date specified in par. 2 and in par. 3 of Article 120 MDR/ 110 IVDR as last amended by regulations.
