The Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety advice for August…
Category: Europe
europe updates on medical device regulation and quality.
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…
Regulatory Alert: Patient Information Leaflet Defect for Hikma Farmacêutica’s Gemcitabine 2g/52.6ml Infusion Concentrate
On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare…
Regulatory Update: Swissmedic Confirms Safety of Paracetamol Use During Pregnancy
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has reaffirmed its position on the use of medicines…
Critical Updates: Field Safety Notices Issued from 8–12 September 2025
Important updates for clinical, quality, and regulatory teams: A series of Field Safety Notices (FSNs) were…