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 in vitro diagnostic medical devices (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 medical devices. State administrative authorities are therefore now granted relatively extensive powers not only to investigate the severity of the shortage but also to directly regulate the market.
The primary mechanism providing the state administration with information regarding the interruption or discontinuation of supply is enshrined in Article 10a of the MDR/IVDR, whereby manufacturers must notify the State Institute for Drug Control (SÚKL) electronically of an interruption or discontinuation of supply at least six months in advance, or without delay in the event of unforeseen circumstances. At the same time, they must inform their customers (distributors and importers) of this fact, thereby triggering a cascade of information, whereby these other entities within the distribution chain are also obliged to inform their own customers. The amendment to the Medical Devices Act does not alter this in any way.
A new development going beyond the scope of this system is a set of new powers granted to the State Institute for Drug Control (SÚKL) and the Ministry of Health. In particular, the SÚKL is authorised to carry out investigations into the availability of medical devices. If there is a suspicion that a shortage of a medical device poses a threat to the provision of healthcare services, the SÚKL may request manufacturers, importers, distributors and hospitals to provide evidence of sales, stock levels, projected trends, etc. It then assesses this evidence.
If, following its investigation, the SÚKL concludes that a shortage of a medical device threatens the availability of healthcare in the Czech Republic, it will forward the documentation to the Ministry of Health and propose a solution to the situation identified. The Ministry of Health may then, through an accelerated procedure, issue a measure of a general nature. Such a measure may temporarily lay down conditions for the placing on the market, prescribing, dispensing or use of the device in question.
Market regulation and possible sanctions
The Ministry of Health may, for example, restrict supplies of a scarce device exclusively to acute hospital care or limit the prescribing of the devices in question to specific diagnoses. As this constitutes an emergency intervention in the free market, its duration is limited to the duration of the shortage, which the State Institute for Drug Control (SÚKL) must review once every three months.
However, to ensure that these are not merely obligations on paper, the amendment also introduces strict penalties. Entities concerned face a fine of up to 5,000,000 CZK for failing to report a shortage to the State Institute for Drug Control (SÚKL), disrupting the flow of information within the distribution chain, failing to cooperate, or breaching measures of a general nature. Liability for non-compliance with the conditions of the measures may now also fall on healthcare providers.
Author: Martin Kárász
