News

FDA – Draft Guidance on Comparative Efficacy Studies in Biosimilar Evaluation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

MDCG 2024-14 Rev.1 – Updated guidance on Master UDI-DI for contact lenses

The MDCG has updated guidance on the use of Master UDI-DI for contact lenses, one of the most widely used medical devices worldwide. The new rules str...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Scientist using a pipette in a laboratory, member of TEAM-NB medical devices association

Strengthening innovation pathways for orphan IVDs under the IVDR: Team-NB advocates regulatory flexibility

In Team-NB Position Paper on Orphan IVDs (July 2025) Team-NB is urging the Commission to create tailored pathways under the IVDR for orphan IVDs—offer...

Izabela Chodara President of the Board
Female doctor with folded arms standing in front of the Swiss flag, representing medical authority and regulation.

Switzerland revises clinical trial documentation requirements – new version of Swissmedic guideline effective June 2025

From June 2025, new rules apply to clinical trial submissions in Switzerland. Sponsors must follow a fixed document structure (eDok_KLV), plan for dua...

Emilia Geszczyńska Project Manager