News

Medical professional reviewing clinical data on a tablet in a modern healthcare environment.

SaMD Under the Spotlight: How to Align EN 62304, MDR/IVDR and the EU AI Act in One Product

Software in MedTech is increasingly expected to meet overlapping requirements: MDR/IVDR as a regulated medical product, EN 62304 as the software life-...

Maciej Dubowik Regulatory Affairs Associate
Gloved hand holding a medical device component used in clinical or dental procedures.

Why borderline products matter more than ever?

More MedTech innovations sit at the intersection of medical devices, medicines, cosmetics or supplements – making early, well-justified product qualif...

Izabela Chodara President of the Board

Regulatory Highlights 2025: The regulatory landscape shaping the European MedTech Sector in 2025

2025 reshaped the European MedTech regulatory landscape. New MDCG guidance, ISO 10993 and GCP R3 set the direction for software, IVDs and clinical res...

Katarzyna Wesołowska Vice President of the Board

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