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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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…
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Symposium: Medical technology in the light of legislative changes and in times of emergency
On October 12, 2020, we participated as a lecturer in a symposium – Medical Technology in the Light of Legislative Changes and in a Time of Emergency. The event was organized by the Aesculap Academy (educational services provided by B. Braun Dialog) in cooperation with the Czech Society for Medical Technology in the premises of…
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Warning for distributors and suppliers of medical devices
The end of the deadline for notification of the medical devices is approaching Dear Distributors and Suppliers of Medical Devices, with the adoption of the new Act No. 268/214 Coll., On Medical Devices and amending Act No. 634/2004 Coll., On Administrative Fees, the agenda for the notification of medical devices was transferred to a new…