The International Medical Device Regulators Forum (IMDRF) has announced the availability of updates from its Working…
Category: Europe
europe updates on medical device regulation and quality.
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…
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…
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…
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…
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…
Breaking News: GHWP Withdraws Membership from IMDRF
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew from the International Medical…
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…
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…
Urgent Notification: Superseded Patient Information in Erythromycin Stearate BP 250mg Tablet Batch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…