A major event shook the entire world of medical devices at the end of November this year. After almost five and a half years of postponements and delays, on November 27, the European Commission published a Decision in the Official Journal of the EU (OJEU) announcing the full functionality of the first four modules of the EUDAMED database. This notification represents a fundamental and absolutely crucial prerequisite for the mandatory use of the EUDAMED database.

The EU has adopted Regulation (EU) 2023/2854 on data (Data Act). The aim is to create a uniform framework for fair and secure sharing of data from connected devices and digital services, strengthen user rights, and promote innovation across sectors. The Data Act will also have a significant impact on healthcare, particularly on medical devices that collect and transmit data on their use or on the patient's health status.

The Ministry of Health has opened the first testing environment for Central Electronic Healthcare Services. The new interfaces will enable healthcare providers and software suppliers to test connections to key national systems and prepare for their live operation. For example, the Root Registry of Patients, Temporary Storage, and eApplications are available.

Every now and then, a new term pops up in Czech healthcare, which then occupies a significant amount of space in public professional discussions, without us being able to tangibly see its practical application in the system. This category certainly includes the areas of digitization, HTA, and AI. However, the Ministry of Health has decided to take a different approach to the issue of telemedicine health services.

On 2 February 2024, the Belgian Presidency announced that the representatives of the EU Member States had already agreed on a final...

We can infer where the medical device market will go in 2024 from the previous year's news. At least partially. The year 2023 would...