Our Delegation at LABS EXPO 2025 in Poznań LABS EXPO 2025 in Poznań (March 19–20) was one of the most important events for the diagnostics and laboratory technology sector in Central Europe. Na...
Joint Discussion Paper – Future Governance of Medical Technologies in the EU Six leading European industry organisations, including MedTech Europe, EFPIA, and EIT Health, have jointly published a vision paper on the future gove...
Remote, but Intense at Health Days 2025 On March 13–14, we took part in the international Health Days 2025 conference held in Vienna. This time, our meetings were conducted remotely — but th...
MDR Regulator at MedTech Summit in Budapest! Last week, for the second consecutive year, we participated in the MedTech Summit in Budapest – one of the key industry events dedicated to medical de... Katarzyna Wesołowska Vice President of the Board
IMDRF Terminologies for Categorized Adverse Event Reporting (AER) The International Medical Device Regulators Forum (IMDRF) has published standardized terminologies for reporting adverse events related to medical dev...
Enhancing Accessibility in Rapid Diagnostic Tests: WHO’s New Guidance Access to accurate and easy-to-use diagnostic tests is essential for public health, but many testing tools are not designed with all users in mind. In...
MFDS of South Korea and HSA of Singapore The Ministry of Food and Drug Safety (MFDS) of Korea and the Health Sciences Authority (HSA) of Singapore have jointly released guiding principles for...
MHRA Guidance on New Medical Devices: Post-Market Surveillance Requirements The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for m... Agnieszka Czajkowska
A year of breakthroughs in medical devices and in vitro diagnostics: Summary of 2024 year The year 2024 has been a time of intensive changes and challenges for the medical device and in vitro diagnostics (IVD) industries. As active particip... Katarzyna Wesołowska Vice President of the Board
