Category: UK

uk updates on medical device regulation and quality.

Europe Regulatory Affairs UK

Profemur Modular Neck Hip Implants: Heightened Risk of Fractures and Revision Surgery Identified

September 30, 2025
H RA

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an important update regarding the risks…

Europe Regulatory Affairs UK

Regulatory Alert: Patient Information Leaflet Defect for Hikma Farmacêutica’s Gemcitabine 2g/52.6ml Infusion Concentrate

September 30, 2025
H RA

On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare…

Europe Regulatory Affairs UK

Critical Updates: Field Safety Notices Issued from 8–12 September 2025

September 30, 2025
H RA

Important updates for clinical, quality, and regulatory teams: A series of Field Safety Notices (FSNs) were…

Europe Regulatory Affairs UK

Critical Updates: Field Safety Notices Issued for Medical Devices (15–19 September 2025)

September 30, 2025
H RA

Healthcare professionals and regulatory teams, please take note. Between 15 and 19 September 2025, a range…