Artificial intelligence (AI) is no longer just a dream of distant future. As a recently published national survey by the Ministry of Health has shown, modern algorithms are gradually becoming a common feature in Czech hospitals and outpatient clinics. Practical experience clearly demonstrates enormous potential for streamlining care; however, experts also caution against blind enthusiasm. The use of uncertified generative models can pose safety risks to both patients and the

In December 2025, the European Commission presented a proposal for a revision of the Medical Devices Regulation (MDR). Its aim is to reduce the administrative burden, strengthen the proportionality of regulatory requirements, and maintain high level of patient protection. The proposed changes significantly affect medical device manufacturers in particular, covering their products entire life cycle. However, it is yet still only a legislative proposal that may change.

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 ap

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 de