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uk updates on medical device regulation and quality.

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84 articles in UK
Europe

Updated Safety Alert: Flutiform 250/10 mcg Inhalation Recall Due to Packaging Error

On September 30, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) announced a Class 2 medicines recall involving specific…

Europe

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 (MHRA) published Field Safety…

Europe

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 medicines and medical devices.…

Europe

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 Clear Sterile Solution/Applicator due…

Europe

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 patients who previously received…

Europe

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 updates requiring close attention…

Europe

Urgent Drug Warning: Outdated Patient Leaflet for Olmesartan Medoxomil Tablets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 tablets. According to the…

Europe

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 users of medicines and…

Europe

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 mg Tablets following routine…

Europe

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 Safety Notices (FSNs) related…

Europe

Medical Alert: Label and Packaging Error Identified for Topiramate Zydus 20mg/ml Oral Solution

Zydus Pharmaceuticals UK Ltd has released a critical notification regarding an error on the packaging and patient information leaflet (PIL)…

Europe

Critical Updates: Field Safety Notices Issued From 4 to 8 August 2025

Clinical, quality, and regulatory teams should note the latest field safety notices issued between 4 and 8 August 2025. These…

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