europe updates on medical device regulation and quality.
258 articles
Swissmedic announces the first authorisation of Tepezza®. This development is significant for quality, clinical, and regulatory professionals monitoring approvals of…
Swissmedic has announced a temporary approval for the distribution of Glucose 5% B. Braun Infusionslösung in German packaging. This decision…
On November 26, 2025, Swissmedic announced the temporary approval for distribution of NaCl 0.9% infusion solution from B. Braun in…
New updates on medical device safety concern all clinical, quality, and regulatory professionals. Between November 17 and November 21, 2025,…
On November 25, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 4 Medicines Defect Notification regarding…
Swissmedic, Switzerland’s key regulatory authority for therapeutic products, has outlined measures to strengthen its financial position. The announcement made 25…
Between 10 and 14 November 2025, significant Field Safety Notices (FSNs) were announced, carrying potential implications for stakeholders across clinical,…
On November 22, 2025, Swissmedic published an important regulatory update announcing the first authorisation of Lutathera®, a therapeutic option designed…
On November 22, 2025, Swissmedic announced the extension of the therapeutic indication for Breyanzi® (lisocabtagene maraleucel). This change has important…
On November 22, 2025, Swissmedic officially granted the first authorization of 18F-PSMA-1007 ZRP®. This approval represents an important milestone in…
Swissmedic has announced the first authorisation of Radelumin®, marking a significant regulatory achievement. Effective November 22, 2025, this authorisation introduces…
Swissmedic, Switzerland’s medical regulatory authority, has announced an important update regarding NexoBrid®. On November 22, 2025, Swissmedic extended the therapeutic…