Registration and Notification
Registration of persons handling Medical Devices and notification of Medical Devices in the Czech Republic after the date of application of MDR until fully functional EUDAMED goes online
As fully functional EUDAMED has not been put into operation yet, the process of person registration and Medical device notification is carried out according to the transitional provisions of Section 74 par. 7 and 8 of the Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices. The above mentioned transitional provision refers to the procedures laid down in the previous legislation i. e. Act No. 268/2014 Coll., effective till May 25th, 2021.
Companies established outside the territory of the European Union have no legal authorisation to be registered in the Registry of Medical Devices, unless they procure the Devices within the territory of the Member States market (distributor). In case, they intend to place products on the Czech market, they have to do so via an economic operator established in a Member State acting in the role of importer.
Companies established outside the territory of the Czech Republic may place Medical Devices on the Czech market from the position of distributor / importer.
An importer shall mean a person established in a Member State who places the medical device on the market, if procured outside the territory of the Member States;
A distributor shall mean a person in the supplier chain, except for the manufacturer or importer, who supplies the medical device procured within the territory of the Member States to the market.
To notify the operation of distributor / importer in the Registry of Medical Device (RZPRO) use Manual No. 1. Once the Certificate of compliance with the notification duty is issued by the State Institute for Drug Control, the module of Medical Devices is made available.
The particulars of Medical device notification process are described in manual Application for Medical Device notification.
In case the Medical device has been already notified in the RZPRO, any other distributor or importer of the concerned Medical device / in vitro diagnostic Medical device shall be obliged to notify the State Institute for Drug Control of the fact that this Medical device is also distributor or imported thereby. The notification proces sis described in manual Medical Device notification according to Section 33 par. 2 of the Act on MD.