Blog

Shaping the future of MedTech professionals – postgraduate program at Bialystok University of Technology

Another inspiring weekend behind us! Our experts from Pure Clinical and MDR Regulator once again led engaging sessions as part of the postgraduate pro...

Agnieszka Czajkowska Senior Regulatory and Clinical Affairs Consultant
MHRA guidance on clinical investigations of medical devices in the UK

Clinical Investigations of Medical Devices in the UK – Updated MHRA Requirements

In the United Kingdom, any clinical investigation involving a non-UKCA/CE-marked device that is not yet commercially available must be submitted for a...

Ilona Korczak-Cegielska Director of Clinical and Regulatory Operations

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 Board Member

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...