Zydus Pharmaceuticals UK Ltd has released a critical notification regarding an error on the packaging and…
Category: Europe
europe updates on medical device regulation and quality.
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…
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…
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…
IMDRF Unveils Affiliate Membership Opportunity for Global Regulatory Authorities
The International Medical Device Regulators Forum (IMDRF) has introduced an important update for medical device regulatory…
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…
Regulatory Updates from the 23rd IMDRF Management Committee Meeting in Brussels
The 23rd Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) took place in…
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)…
Key Learnings from the 23rd IMDRF Workshop: Enhancing Post-Market Surveillance in Medical Device Regulation
On September 30, 2025, the International Medical Device Regulators Forum (IMDRF), together with DITTA and GMTA,…
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…