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...

Not much is happening legislatively during the Chamber summer recess. However, an exception is the reduction in payments for state...

It has been a little over a year now since similar legislation on advertising for medical devices to that for pharmaceuticals began to...

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...