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uk updates on medical device regulation and quality.

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84 articles in UK
Europe

Urgent Update: Safety Information Missing in Levetiracetam Accord Oral Solution Documents

Accord Healthcare Limited, UK has formally notified the Medicines and Healthcare products Regulatory Agency (MHRA) of a critical defect related…

Europe

Critical Updates: Field Safety Notices Issued for Medical Devices (11–15 August 2025)

Healthcare professionals, regulatory experts, and clinical teams take note: field safety notices (FSNs) issued between 11 and 15 August 2025…

Europe

Important Notification: Barcode Error on Fexofenadine Hydrochloride 120mg Tablets by Chanelle Medical

The Medicines and Healthcare products Regulatory Agency (MHRA) has been notified about a barcode error affecting specific batches of Fexofenadine…

Europe

Critical Updates: Field Safety Notices for Medical Devices Issued from 5 to 9 May 2025

Medical device users and healthcare teams should note the publication of new Field Safety Notices (FSNs) from 5 to 9…

Europe

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…

Europe

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,…

Europe

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…

Europe

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.…

Europe

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…

Europe

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 products Regulatory Agency (MHRA)…

Europe

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 published between 8 and…

Europe

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

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

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