News

Laboratory quality control process with sterile sample tubes and validated handling procedures in a regulated medical environment.

Building a Durable Evidence Base for IVDs through Sample Biobanking

IVDR requires that the performance of in vitro diagnostic (IVD) devices be assessed continuously throughout the product’s lifecycle. Access to biobank...

Wioletta Piotrowska Clinical Research Associate
Digital healthcare compliance concept illustrating integrated quality management and regulatory oversight in the medical device sector.

ALCOA in Medical Device Clinical Investigations: From Slogan to Rigorous Data Quality Requirements

In medical device clinical investigations, it is easy to focus solely on "major themes" such as the clinical investigation plan (CIP) or participant s...

Tatiana Dolińska Clinical Research Scientist
Medical laboratory samples with United Kingdom flag in the background representing UK regulatory framework for medical devices.

CE Recognition UK 2026 – UK medical device regulation changes and the future of CE marked devices in Great Britain

CE Recognition UK 2026 may become the most important regulatory shift in Great Britain since Brexit. MHRA is considering indefinite acceptance of CE m...

Adrianna Pyrzanowska Regulatory Affairs Associate
Healthcare professional using a digital device with a warning symbol, representing medical data compliance and risk management.

MDCG 2025–10: guidance on post-market surveillance (PMS) of medical devices (MDs) and in vitro diagnostic medical devices (IVDs)

MDCG 2025–10 brings practical clarity to post-market surveillance by outlining what an effective PMS system should look like for medical devices and d...

Agnieszka Mroczek-Krakowian Clinical Research Scientist
Laboratory technician transferring liquid sample into a test tube during clinical research.

ICH E6 (R3) Good Clinical Practice – what changed in 2025?

ICH E6 (R3) reshapes Good Clinical Practice by emphasizing end-to-end quality and proportionate risk management. The principles-based structure and an...

Lucyna Szczech Clinical Trial Manager
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