In the second half of January, the Constitutional Court issued a fairly inconspicuous but absolutely crucial decision for real practice....

On 15 February 2023, the European Parliament has almost unanimously supported a proposal to amend the EU Medical Devices and In Vitro...

On 6 January 2023, the European Commission adopted a proposal to extend the transition period for the re-certification of so-called...

The end of the transition period for so-called legacy devices (medical devices provisionally placed on the market on the basis of...

Soon we will be moving into the second half of the transition period for "flipping" legacy devices into MDR mode. Unfortunately, as...

Medical devices and medicinal products are two completely differently regulated categories of products that cannot be mixed and confused....

A useful tool for all medical device software developers considering the use of artificial intelligence (AI) and machine learning (ML)...

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...

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