On September 30, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) announced a Class 2…
Category: Europe
europe updates on medical device regulation and quality.
Critical Update: Field Safety Notifications Released for Medical Devices (22–26 September 2025)
In a recent regulatory update crucial for healthcare professionals, the Medicines and Healthcare products Regulatory Agency…
Critical Safety Update: MHRA Reinforces September 2025 Guidelines for Medicines and Device Users
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its September 2025 safety update for…
Urgent Recall Alert: Packaging Seal Defect Identified in ChloraPrep 1mL Applicators
Becton Dickinson UK Ltd has issued a notification to recall certain batches of its ChloraPrep 1mL…
Critical Update: Revised UK Guidance on Managing Endologix Nellix EVAS System Recall
The Medicines and Healthcare products Regulatory Agency (MHRA) has released significant updates regarding the management of…
Critical Field Safety Notices Alert: Updates from 21–25 July 2025
Field safety notices issued between 21 and 25 July 2025 have highlighted significant device recalls and…
Urgent Drug Warning: Outdated Patient Leaflet for Olmesartan Medoxomil Tablets
Jubilant Pharmaceuticals NV has reported a packaging error involving certain batches of Olmesartan medoxomil 10mg film-coated…
July 2025 MHRA Safety Update: Essential Guidance for Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety guidance aimed at…
Fucidin 250 mg Tablets Recall Announced Due to Impurity Concerns
On September 30, 2025, LEO Pharma issued a recall notice for one batch of Fucidin 250…
Critical Updates: Field Safety Notices for Medical Devices (28 July – 1 August 2025)
Between 28 July and 1 August 2025, healthcare teams were informed of updates to multiple Field…