Implementing Regulation (EU) 2026/977 represents a fundamental procedural reform of the conformity assessment of medical devices under the MDR and IVDR. The stated goal is to harmonize differing interpretations of the regulations and the fragmented practices of notified bodies, increase transparency, and ensure market predictability—all without compromising patient safety, according to the Commission. The regulation is going to take effect on February 25, 2027.

This time, we will focus on the specifics of distribution and retail. Here, the new terms and obligations clash with strict sector-specific regulations under the MDR and IVDR; fortunately, the PPWR provides important exemptions to protect patient safety. These exemptions apply primarily to packaging that is sensitive to contact with the medical device, while group and transport packaging in the supply chain will not be exempt from the new strict environmental limits.

The rules governing the advertising of MDs and IVDs are set to undergo a significant overhaul. Although the originally proposed amendment to the Advertising Regulation Act was not debated during the previous legislative session, it is now returning to the Chamber of Deputies as Bill No. 153. In addition, the proposal also addresses the necessary implementation of European legislation on infant formula. If the legislative process proceeds as usual, the new rules will take effe

The EU is introducing changes to product packaging rules. The new Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) introduces stricter requirements for eco-design, recyclability, and packaging minimization. The changes will also affect the medical device sector, which is primarily governed by the MDR and IVDR. Although the PPWR generally applies to all packaging placed on the market, it introduces some exceptions for medical devices to protect patient safety an

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.