The International Medical Device Regulators Forum (IMDRF) has provided a detailed progress report on its Strategic…
Category: Europe
europe updates on medical device regulation and quality.
Critical Updates on Medical Device Field Safety Notices Issued from 18 to 22 August 2025
Between 18 and 22 August 2025, several Field Safety Notices (FSNs) were issued for medical devices,…
Stay Updated on IMDRF Developments: A New Way to Access Alerts
Attention clinical, quality, and regulatory professionals: the International Medical Device Regulators Forum (IMDRF) is making it…
Essential MHRA Updates: August 2025 Safety Guidance for Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety advice for August…
Review and Provide Feedback on IMDRF Regulatory Updates from the 24th Management Committee Session
The International Medical Device Regulators Forum (IMDRF) has announced updates from its Working Groups, which are…
Medical Device Field Safety Notices: Updates from August 25–29, 2025
Field Safety Notices issued between August 25 and 29, 2025, provide crucial updates for stakeholders involved…
IMDRF’s Safety and Performance Workshop: Key Insights for Regulatory Professionals
The International Medical Device Regulators Forum (IMDRF) held a two-part workshop on September 11 and September…
Profemur Modular Neck Hip Implants: Heightened Risk of Fractures and Revision Surgery Identified
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an important update regarding the risks…
IMDRF Digitalizes Membership Applications: New Online Platform Launches
Clinical, quality, and regulatory teams take note: Starting May 2025, the International Medical Device Regulators Forum…
Scemblix® Gains Extended Therapeutic Indication Approval from Swissmedic
Swissmedic has officially announced an extension of the therapeutic indications for Scemblix®, a drug that plays…