Markéta Hrubá

Medical Device Coordination Group (MDCG) has published the first comprehensive guide to working with so-called Breakthrough Devices (BtX) under the MDR/IVDR. It supports accelerated market access for innovations with major clinical benefits for patients with serious, life-threatening or irreversibly debilitating diseases without easing clinical evidence requirements. It also defines actors’ roles and sets a framework for the distribution of clinical evidence when placing a device on the market.

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 European Commission has launched a review of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The aim is to reduce the administrative and financial burden, which in practice mainly affects smaller manufacturers and hinders innovation. The Czech Republic actively participated in the consultations and sent its comments and suggestions for improvement to Brussels.