Check information about EU Medical market ⚕️ Pure Clinical

MHRA – Updated Guidance on Clinical Investigations of Medical Devices in the United Kingdom

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released an updated Guidance for Manufacturers on Clinical Investigations of Med...

Agnieszka Czapko Head of Regulatory and Start-up Department

AI & MedTech CEE 2025: Conversations on the Future of Artificial Intelligence in Healthcare

On 26–27 September 2025, our team visited Riga to attend Medbaltica – the largest medical trade fair in the Baltic States. The event highlighted the l...

Fryderyk Janiak Business Development Manager

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 Board Member

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...