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europe updates on medical device regulation and quality.

258 articles
258 articles in Europe
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Critical Update: Barcode Error Identified in Simvastatin 10mg From Crescent Pharma

Crescent Pharma Limited has reported a significant issue related to one of its distributed products, Simvastatin 10mg Tablets, in the…

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Zaditen Eye Drops Recall Announced Over Microbial Contamination Risks

In a recent update concerning pharmaceutical safety, Thea Pharmaceuticals Limited (trading as Laboratoires Théa) initiated a Class 2 Medicines Recall…

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Critical Updates: Field Safety Notices Released for 30 June to 4 July 2025

Healthcare professionals specializing in clinical, quality, and regulatory affairs should note the latest developments regarding medical device safety. A comprehensive…

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Critical Updates: Field Safety Notices Published for Medical Devices (7–11 July 2025)

Healthcare professionals and teams responsible for compliance and patient safety should take note of the latest Field Safety Notices (FSNs)…

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Latest Field Safety Notices Highlight Critical Updates for Medical Devices: 14–18 July 2025

Medical device professionals should be aware of the latest Field Safety Notices (FSNs) published between 14 July and 18 July…

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Critical Update: Positive Bias Detected in Trinity Biotech Premier Hb9210™ HbA1c Analyser Results

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert regarding the Trinity Biotech Premier Hb9210™ HbA1c…

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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…

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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…

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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.…

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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…

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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…

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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…

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