Blog

ISO 14155:2020 – Upcoming Revisions to the GCP Standard for Clinical Investigations of Medical Devices

The International Organization for Standardization (ISO) is finalizing updates to ISO 14155:2020 to align Good Clinical Practice (GCP) with the realit...

Małgorzata Pawlikowska Head of Clinical Study Department

FDA – Draft Guidance on Comparative Efficacy Studies in Biosimilar Evaluation

The U.S. Food and Drug Administration (FDA) has proposed a major revision to its biosimilar guidance, outlining when comparative efficacy studies (CES...

Adrianna Pyrzanowska Regulatory Affairs Associate

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

Pure Clinical at the We! Are Clinical Research Conference

Three days filled with inspiration, knowledge, and discussions with people deeply involved in the world of clinical research. Izabela Chodara, Direct...

Izabela Chodara Director of Strategy and Operations

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