Key Learnings from the 23rd IMDRF Workshop: Enhancing Post-Market Surveillance in Medical Device Regulation
On September 30, 2025, the International Medical Device Regulators Forum (IMDRF), together with DITTA and GMTA, published key findings from…
Europe
europe updates on medical device regulation and quality.
258 articles
258 articles in Europe
Latest News
Latest News
Important Regulatory Notification: Patient Safety Gaps Identified in Ipca Laboratories UK Ltd PILs
On September 30, 2025, Ipca Laboratories UK Ltd issued an urgent notification to the Medicines and Healthcare products Regulatory Agency…
Latest News
IMDRF Releases Progress Update on Strategic Plan 2021-2025
The International Medical Device Regulators Forum (IMDRF) has provided a detailed progress report on its Strategic Plan for 2021-2025. Released…
Latest News
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, alerting clinicians, regulatory staff,…
Latest News
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 easier for stakeholders to…
Latest News
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 2025, addressing crucial updates…
Latest News
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 now available for review…
Latest News
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 in medical device oversight.…
Latest News
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 19, 2024, concentrating on…
Latest News
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 associated with Profemur cobalt…
Latest News
IMDRF Digitalizes Membership Applications: New Online Platform Launches
Clinical, quality, and regulatory teams take note: Starting May 2025, the International Medical Device Regulators Forum (IMDRF) is transitioning its…
Latest News
Scemblix® Gains Extended Therapeutic Indication Approval from Swissmedic
Swissmedic has officially announced an extension of the therapeutic indications for Scemblix®, a drug that plays a pivotal role in…
Loading more articles…