Blog

Scientist in a laboratory working on a computer with data displayed on the screen, viewed from behind.

FDA issues final guidance on Computer Software Assurance in production and quality systems

On 24 September 2025, the FDA published its final guidance on Computer Software Assurance (CSA) for software used in medical device manufacturing and...

Maciej Dubowik Regulatory Affairs Associate
Tablet displaying text on a desk next to open books in a modern office or research library.

Borderline & Classification Manual 2025 – clarifying MDR/IVDR borderline cases

In September 2025, version 4 of the MDCG Borderline Manual was published. It provides guidance on products on the borderline between MDR and other leg...

Adrianna Pyrzanowska Regulatory Affairs Associate

Pure Clinical and MDR Regulator at GMES 2025 in South Korea

Last week, our experts took part in the GMES Conference in South Korea – one of the most significant MedTech events in Asia. The visit offered not onl...

Katarzyna Wesołowska Vice President of the Board

New restrictions on CMR substances (Carcinogenic, Mutagenic and Reprotoxic) in the EU – Commission Regulation (EU) 2025/1731

The EU has tightened restrictions on carcinogenic, mutagenic and reprotoxic (CMR) substances used in medical devices. Manufacturers will need to reass...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
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...