A comprehensive act regulating both the MDs and IVDs is finally here. The new Act No. 375/2022 Coll., on medical devices and in vitro...

New Regulation of the European Parliament and of the Council (EU) 2022/123 of 25 January 2022 on reinforced role for the European...

The issue of mail-order dispensing of medical devices has been an evergreen in recent years. While mail-order dispensing of prescription...

In recent years, conflicts between VZP and suppliers have been escalating over the inclusion of separately charged material (ZUM) in the...

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