Critical Updates: Field Safety Notices Issued for Medical Devices (13–17 October 2025)
Field Safety Notices (FSNs) issued between 13 and 17 October 2025 have been published, bringing critical updates for clinical, quality,…
Europe
europe updates on medical device regulation and quality.
258 articles
258 articles in Europe
Latest News
Latest News
Swissmedic Update: Revised EU Medical Device Regulations Explained
On October 21, 2025, Swissmedic announced updates to key sections related to EU legal acts for medical devices. These revisions…
Latest News
Temporary Authorization Issued for Seroquel XR 50 mg Tablets in Italian Packaging
On October 20, 2025, Swissmedic announced a temporary resolution to the supply shortage of Seroquel XR 50 mg retard tablets…
Latest News
Swissmedic Grants Initial Approval for Imcivree®: What You Need to Know
Swissmedic has officially granted the initial authorisation for Imcivree®. This significant regulatory decision is vital for stakeholders in the clinical,…
Latest News
Swissmedic Announces Limited Distribution Approval for Opdivo 40 mg/4 ml Infusion Concentrate Amid Supply Challenges
Swissmedic has issued a temporary authorization permitting the distribution of Opdivo 40 mg/4 ml Konzentrat zur Herstellung einer Infusionslösung in…
Latest News
Urgent Recall of Similasan Schnupfen Globuli Batch 17900 Announced by Swissmedic
On October 16, 2025, Swissmedic issued an urgent announcement regarding the recall of batch 17900 of Similasan Schnupfen Globuli (15g),…
Latest News
Critical Updates on Field Safety Notices Issued from 6–10 October 2025
Between 6 October and 10 October 2025, several Field Safety Notices (FSNs) were published, signaling important updates and concerns for…
Latest News
Urgent Recall Issued for Nobivac DHPPi Veterinary Injection for Dogs
On October 15, 2025, Swissmedic announced a batch recall of the veterinary medicine Nobivac DHPPi, a lyophilisate designed for the…
Latest News
Swissmedic Highlights Regulatory Focus on Parenteral Cosmetic Products
Swissmedic has released key insights on parenteral products in the cosmetic sector. This update, published on October 13, 2025, emphasizes…
Latest News
Swissmedic Grants First Authorization for Balversa® in Targeted Cancer Treatment
On October 10, 2025, Swissmedic issued its first authorization for Balversa®, marking a significant milestone in precision oncology. This pivotal…
Latest News
Swissmedic Approves Extended Use for Spevigo®: Important Regulatory Update
Swissmedic has officially approved an extension of the therapeutic indication for Spevigo®. This regulatory decision marks a refined update to…
Latest News
Swissmedic Grants Initial Authorization for Voxzogo®: A Milestone for Regulatory Compliance
Swissmedic, the Swiss agency for therapeutic products, has officially granted the first authorization for Voxzogo®, marking a significant step forward…
Loading more articles…