News

MDR and IVDR Reform: A Structural Recalibration of the EU Medical Devices Regulatory Framework

The European Commission has published a long-anticipated proposal for the reform of the MDR and IVDR. The initiative represents a comprehensive attemp...

Katarzyna Wesołowska Vice President of the Board
European Union healthcare regulation concept illustrating medical device compliance, patient safety and health system resilience

New EU measures to build a more innovative, competitive and resilient health sector

The European Commission has presented a comprehensive package of measures aimed at strengthening innovation, competitiveness and resilience across the...

Agnieszka Czapko Head of Regulatory and Start-up Department
Medical professional reviewing FDA regulatory documentation and real-world evidence data on a laptop in a clinical compliance context

FDA removes a major barrier to Real-World Evidence: implications for medical device and IVD regulation

The U.S. Food and Drug Administration has announced a significant policy shift that removes one of the key barriers to the use of real-world evidence...

Adrianna Pyrzanowska Regulatory Affairs Associate
Advanced in vitro diagnostics laboratory with microscope and precision pipetting during medical device research and testing

In Vitro Diagnostics Medical Device Roadmap: a strategic outlook for IVDR implementation and innovation

The publication of the In Vitro Diagnostics Medical Device Roadmap marks a shift from reactive regulatory problem-solving towards proactive, strategic...

Małgorzata Pawlikowska Head of Clinical Study Department
Healthcare professionals discussing innovative medical devices in a modern hospital environment under EU MDR and IVDR regulations

Breakthrough Devices under MDR and IVDR – Regulatory Framework Clarified by MDCG 2025-9

The MDCG 2025-9 guidance introduces, for the first time, a structured and system-wide EU interpretation of breakthrough devices under MDR and IVDR. Ra...

Izabela Chodara President of the Board
Medical engineers reviewing equipment and documentation in a clinical technology environment — compliance with EU MDR and EUDAMED requirements.

EUDAMED approaches full operational Status: New duties for EU Economic Operators

As EUDAMED nears full operational status, manufacturers, importers, authorised representatives and notified bodies must prepare for mandatory registra...

Adrianna Pyrzanowska Regulatory Affairs Associate
Mężczyzna stojący przed stoiskiem Warsaw Medical Expo podczas konferencji medycznej 2025 – wydarzenie branży ochrony zdrowia, okulistyka i zarządzanie opieką zdrowotną.

Pure Clinical at Warsaw Medical Expo 2025 – insights, networking, and innovation

The November event marathon continued as Fryderyk Janiak, Business Development Manager at Pure Clinical, engaged in valuable discussions and gained ne...

Fryderyk Janiak Business Development Manager
Scientist in protective suit performing chemical characterization tests in a medical laboratory — ISO 10993-1:2025 biological safety evaluation.

ISO 10993-1:2025 – new foundations for biological evaluation under the MDR

The 2025 revision of ISO 10993-1 introduces a more rigorous, evidence-driven system for biological evaluation, placing greater emphasis on chemical ch...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Engineer analyzing medical device user interface on multiple monitors — usability and human factors according to ANSI/AAMI HE75:2025.

Applying ANSI/AAMI HE75:2025 – Human Factors as a atrategic asset in medical device design

The revised ANSI/AAMI HE75:2025 reframes human factors and usability as central drivers of safe and effective medical device design. By structuring us...

Małgorzata Pawlikowska Head of Clinical Study Department