News

ISO 13485:2016 reconfirmed – regulatory and quality system stability secured until 2030

During the recent ISO/TC 210 Working Group 1 meeting held in Arlington, Virginia, it was officially confirmed that ISO 13485:2016 remains valid and un...

Katarzyna Wesołowska Vice President of the Board

FDA launches real-time reporting of adverse event data

What this means for stakeholders Patients: immediate visibility of new adverse events linked to marketed products. Healthcare professionals: timely si...

Adrianna Pyrzanowska Regulatory Affairs Associate

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FDA – Draft Guidance on Comparative Efficacy Studies in Biosimilar Evaluation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
Close-up of scientists in lab coats writing notes on paper in a research laboratory.

Updated MHRA requirements for clinical investigations of medical devices

In September 2025, the MHRA published harmonised guidance and validation checklists for sponsors and investigators planning clinical investigations in...

Małgorzata Pawlikowska Head of Clinical Study Department
Laboratory with digital cloud network visualization above computers and equipment, symbolizing data connectivity.

Data Act and medical devices: new IoT data-sharing obligations

The EU Data Act (Regulation (EU) 2023/2584) will apply from 2026. The September 2025 FAQs clarify how IoT data-sharing rules apply to medical devices...

Katarzyna Wesołowska Vice President of the Board

Australian TGA issues guidance on regulating Software as a Medical Device (SaMD)

Australia’s TGA has released new guidance for Software as a Medical Device (SaMD), with strong focus on AI and adaptive algorithms. The document outli...

Maciej Dubowik Regulatory Affairs Associate