Swissmedic Introduces Horizon Scanning Platform to Enhance Regulatory Oversight
Swissmedic has unveiled a new horizon scanning website to improve proactive regulatory measures. This initiative aims to streamline the identification…
Europe
europe updates on medical device regulation and quality.
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258 articles in Europe
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IMDRF Working Group Updates Open for Feedback: Key Regulatory Insights
The International Medical Device Regulators Forum (IMDRF) has announced the availability of updates from its Working Groups, which are set…
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Critical Updates on Field Safety Notices Issued Between 16 to 20 June 2025
The UK Government has released a detailed summary of Field Safety Notices (FSNs) issued from 16 to 20 June 2025.…
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Building Global Capacity for Medical Device Safety: IMDRF Workshop Insights
The International Medical Device Regulators Forum (IMDRF) held a pivotal two-part workshop on 11 and 19 September 2024. This initiative…
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Regulatory Alert: Recall of Kimmtrak 200 micrograms/mL Due to Potency Issues
Immunocore Limited is urgently recalling specific batches of its Kimmtrak 200 micrograms/mL concentrate for solution for infusion after stability testing…
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IMDRF Launches Online Membership Forms: A Streamlined Submission Process
From May 2025, regulatory professionals and other stakeholders involved with medical device oversight will benefit from an important update. The…
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Urgent Recall: Depo-Medrone Labeling Error Poses Dosage Risk
A recall has been issued for a batch of Depo-Medrone 80 mg in 2 mL vials due to a critical…
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Breaking News: GHWP Withdraws Membership from IMDRF
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew from the International Medical Device Regulators Forum (IMDRF),…
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Urgent Recall of Batch-Specific Omeprazole Oral Solution Due to Quality Concerns
On October 2, 2025, Glenmark Pharmaceuticals Europe Ltd announced a precautionary recall of a specific batch of its Omeprazole 20…
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Tamoxifen 20mg Tablets Recall: Stability Testing Uncovers Dissolution Issue
Wockhardt UK Limited issued a precautionary recall of a batch of Tamoxifen 20mg film-coated tablets after stability testing revealed a…
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Urgent Notification: Superseded Patient Information in Erythromycin Stearate BP 250mg Tablet Batch
Amdipharm UK Ltd has reported a critical issue regarding a batch of Erythromycin Stearate BP 250mg tablets. The Patient Information…
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Critical Advisory: New Aurum 10ml CONNECT Syringe Barrel Requires Compatible Needle-Free Connectors to Prevent Blockages
Healthcare professionals are urged to adopt compatible needle-free connectors (NFCs) with the newly phased-in Aurum 10ml CONNECT syringe barrels. This…
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