Check information about EU Medical market ⚕️ Pure Clinical

Doctor analyzing patient data on a digital tablet with medical statistics on screen

When is software a device? Clarifying qualification criteria for IVD software under the IVDR

This new Team-NB Position Paper on Software Qualification cuts through the ambiguity of software qualification under the IVDR, offering actionable cri...

Adrianna Pyrzanowska Regulatory Affairs Associate

Participant at the 6th Central European Biomedical Congress 2025 in Krakow, standing next to the event banner focusing on neuropharmacology and AI in bioinformatics

In Kraków: The Future of Neuropharmacology and AI in Healthcare

From July 22 to 24, 2025, we took part in the 6th edition of the Central European Biomedical Congress (CEBC) – an event dedicated to the applications...

Fryderyk Janiak Business Development Manager

Close-up of a person inserting a soft contact lens into their eye, highlighting optical medical device usage

Master UDI-DI for optical devices – timelines and labeling rules clarified by MDCG

The MDCG outlines in the MDCG 2025-7 Position Paperphased timelines for implementing the Master UDI-DI for highly individualized optical devices, incl...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

Smiling man in a navy suit and glasses standing in front of AI & MedTech CEE 2025 conference screen showing event date and tech-themed background

AI & MedTech CEE 2025: shaping the future of healthcare AI

On June 10, we had the opportunity to attend the AI & MedTech CEE conference – a meeting of innovators, regulators, and visionaries shaping the future...

Group of four business professionals posing in front of Health Business Innovation 2025 backdrop at the Regional Chamber of Commerce in Katowice

Health Business Innovation 2025 – shaping the future of MedTech in Katowice

On June 5, we participated in Health Business Innovation 2025 in Katowice – an inspiring event full of practical insights and forward-thinking discuss...

Pure Clinical at the 11th “Clinical Trials Are for You” Conference

On the occasion of International Clinical Trials Day, the Pure Clinical team participated in the 11th edition of the “Clinical Trials Are for You” con...

LifeScience4EU Conference 2025 – wrapped up!

Two intensive yet remarkably fruitful days of engaging discussions, expert panels, and meaningful networking marked the LifeScience4EU Conference 2025...

Red pill with white Swiss cross symbol representing Swiss pharmaceutical or healthcare industry, placed among other medical capsules.

Switzerland implements simplified market access pathway for high-risk medical devices

Switzerland has adopted regulatory changes enabling temporary authorization for high-risk medical devices even without MDR or Swiss approval. The law...

Katarzyna Wesołowska Board Member

Team-NB Updates Best Practice Guidance on MDR Technical Documentation

The updated Team-NB guidance on technical documentation provides manufacturers with a comprehensive framework to build MDR-compliant technical files...