Blog

Changes in the guidance on MDR appropriate surveillance – MDCG 2022-4 Rev. 2

Are you the manufacturer who is using the transitional provisions? This guidance is for you. According to Article 120(3e) of the MDR, the notified bod...

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

Switzerland Introduces Simplified Market Access for High-Risk Medical Devices – A New Pathway for Innovation and Critical Situations

Key Provisions of the Federal Council RegulationSwissmedic, the Swiss Agency for Therapeutic Products, may now temporarily authorize high-risk medical...

Katarzyna Wesołowska Vice President of the Board

Health Business Innovation 2025 – Discussions on the Future of MedTech in Katowice

A Space for Dialogue on the Future of Healthcare Innovation The conference served as a platform for open discussions on the challenges faced by MedTec...

Fryderyk Janiak Business Development Manager
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FDA – Draft Guidance on Comparative Efficacy Studies in Biosimilar Evaluation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 President of the Board