The Czech Republic expects the new EU medical device and in vitro diagnostic regulations will pose a significant regulatory burden to its domestic devicemakers.

In the past, for example, the country’s postmarket surveillance was fragmented. The new regulations included a new register of medical devices and the Czech Ministry of Health is now responsible for registering devices and postmarket surveillance. The new law introduced more stringent penalties and sanctions, as well as price checks.

The Czech healthcare system is mostly financed by the public sector, and securing reimbursement from public and private health insurers has been a longstanding industry struggle. The Czech Constitutional Court has ruled that the current reimbursement system must be replaced with a more transparent system by the end of 2018.