Temporary Approval Granted for Imjudo Infusion Solution in German Packaging
Swissmedic has announced a temporary market authorization for Imjudo, a concentrate used in the preparation of an infusion solution. This…
Europe
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258 articles in Europe
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Essential Field Safety Notices: Key Updates from 2–6 June 2025
In early June 2025, a series of Field Safety Notices were issued highlighting updates and recalls for medical devices across…
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Spotlight on Post-Market Surveillance: Insights from the 23rd IMDRF Session Joint Workshop
Meta description: A new white paper highlights essential observations from the 23rd IMDRF Session Joint Workshop on enhancing post-market activities…
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Critical Update: Incorrect Dose Instruction on Dulcolax 5mg Tablets Outer Carton
On October 2, 2025, Opella Healthcare UK LTD issued an urgent notification regarding a packaging error for the outer carton…
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Urgent Veterinary Recall: Revozyn RTU 400 mg/ml for Cattle Affected
Swissmedic has issued an urgent announcement concerning the recall of a specific batch of the veterinary medicine Revozyn RTU 400…
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Essential Recall Alert: Inhixa 12,000IU Injection Packaging Error Announced
Meta description: Maxearn Limited recalls Inhixa 12,000IU injection due to carton labeling error. Learn about the issue, impact, and actions…
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IMDRF Publishes Strategic Plan Progress Report for 2021-2025
The International Medical Device Regulators Forum (IMDRF) has released a vital progress document detailing advancements under its 2021-2025 Strategic Plan.…
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Swissdamed UDI Devices Module Adds Discard Functionality for Compliance Teams
On October 2, 2025, Swissmedic announced a key update to the Swissdamed UDI Devices module. The new discard functionality enables…
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May 2025 MHRA Safety Updates: Key Guidance for Medicine and Medical Device Users
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its May 2025 Safety Roundup, providing updated safety guidelines and…
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Stay Updated on Key IMDRF Updates and Consultations
The International Medical Device Regulators Forum (IMDRF) has introduced a convenient way for clinical, quality, and regulatory professionals to stay…
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Swissmedic Introduces Preliminary Decision Clarification Meetings for Human Medicinal Products
Swissmedic has announced an important update for stakeholders involved in authorisation procedures for human medicinal products. Starting soon, a new…
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MHRA’s Latest Safety Guidance: Key Updates for Medical and Device Users – June 2025 Edition
The Medicines and Healthcare products Regulatory Agency (MHRA) has released the latest safety guidance for medication and medical device users…
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