The year 2021 was a turning point for the regulation of medical devices, both in terms of national legislation and at the level of the...

When MDR and IVDR were approved in 2017, it was foreseen that the MDR would enter into mandatory application on 26. 5. 2020 and the IVDR...

In 2020, we were hit by the first wave of the COVID-19 pandemic, and at the same time the Medical Devices Act (current Act No. 89/2021...

Relatively aside, even within our own office, was the document MDCG 2021-3 - Questions and Answers on Custom Made Devices, for Czechs the...