Contributions concerning the latest information from the legislation on medical devices, our professional activities and other topics related to health issues and the provision of health services.
-
Expiration of Activity in ISZP
Last year, there was a change in the reporting agenda for distributors and service providers in the Czech Republic. Notification for these entities is conducted in the Medical Devices Information System (ISZP). The data of distributors and service providers who had a valid registration in the Medical Devices Register (RZPRO) at the time of the…
-
Electronic operator registration system
The first EUDAMED module, launched on 1 December 2020, is the electronic operator registration system. All economic operators (EU and non-EU manufacturers, authorized persons, systems & procedure pack kit producers, importers) must register with EUDAMED and provide the necessary information. Economic operator registration process (excluding non-EU manufacturers) Sending the application for registration – electronically Assessment…
-
Exception for antigenic tests for COVID-19 self-testing
On February 24, 2021, the company Dialab spol. s r.o. obtained the exception of placing a medical device on the market in the Czech Republic. This exemption concerns two medical devices that can be used for self-testing on COVID-19 and their use is in the interest of public health protection. The application submitted to the…