Blog

Scientist using microscope in laboratory. Close-up of a researcher's hands adjusting a modern microscope in a lab setting

Master UDI-DI for Optical Devices – MDCG Clarifies Timelines and Labelling Rules

Purpose of the Measure In accordance with Article 27 of the MDR and related delegated regulations, the introduction of the Master UDI-DI aims to simpl...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

Medbaltica 2025 in Riga – Innovations and Emerging Trends in MedTech

A New Perspective on Healthcare Trends Medbaltica 2025 attracted exhibitors from across Europe, showcasing modern diagnostic devices, rehabilitation t...

Fryderyk Janiak Business Development Manager

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FDA – Draft Guidance on Comparative Efficacy Studies in Biosimilar Evaluation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
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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