Markéta Hrubá

Since January 1, 2026, ePoukaz is mandatory, with paper forms only permitted in strictly defined cases. The introduction of ePrescriptions is intended to reduce errors in filling out forms, limit duplicate prescriptions, speed up approval by health insurance companies, and minimize opportunities for fraud. According to the State Institute for Drug Control, it also provides greater comfort and safety for patients, who have their medical devices clearly listed in the eRecept application.

The European Commission has presented a large package of measures aimed at strengthening innovation, competitiveness, and resilience in European healthcare. The proposal is based on three pillars – the Biotech Act, the revision of the MDR and IVDR, and the new Safe Hearts Plan – and aims to simplify regulation, reduce administrative burden, and accelerate the transfer of innovation into clinical practice while maintaining a high level of patients' protection.

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.