Recent reports of the repeated use of single-use medical devices in some Czech hospitals have sparked a wave of debate and understandable concerns about patient safety. A closer look at the situation, however, reveals that this is not a matter of isolated failures, but rather a much broader phenomenon. This stems directly from economic pressure on healthcare facilities and likely occurs to varying degrees across the entire sector.

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.

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

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.

Following extensive postponements, the European Commission has at last issued a Decision on the notice regarding the full functionality of first four EUDAMED database modules in the Official Journal of the EU (OJEU) on November 27, 2025.

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.

EUDAPORT is a new complex service that offers manufacturers of medical devices and IVDs a fast and user-friendly way to prepare, check and bulk upload data to the EUDAMED database as part of mandatory registrations.

March 2 is approaching, bringing with it the obligation to review and confirm their data in the ISZP system.

The Czech Standardization Agency & Porta Medica published "Transition Guide to the MDR" that explains key changes in the MD regulation.