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.
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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…
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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…
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European Databank on Medical Devices – EUDAMED
As part of the implementation of the requirements of the EU Regulation 745/2017 on medical devices and the EU Regulation 746/2017 on in vitro diagnostic devices, the EUDAMED information system was extended (this is a significantly more widespread database compared to the current version of the database). An important change is that some information from…