Amendment to the Act on Medical Devices to Ensure the Availability of Medical Devices
An amendment to Act No. 375/2022 Coll., on medical devices and IVDs (the ‘Medical Devices Act’), has been in effect since September 2026, introducing a new framework into Czech law for addressing supply shortages of medical devices. It introduces previously lacking domestic instruments to mitigate such situations. As the explanatory memorandum emphasises, without this amendment, the state would have no option but to declare a state of emergency in response to a critical shortage of key MDs.