Europe

europe updates on medical device regulation and quality.

258 articles
258 articles in Europe
Latest News

Recall of Similasan Schlafstörungen Globuli Due to Quality Issues: Regulatory Implications for Swiss Market

As of February 11, 2026, Swissmedic announced a recall of Similasan Schlafstörungen Globuli due to quality issues affecting the product’s…

Latest News

Swissmedic Announcement: Understanding the Jarisch-Herxheimer Reaction During Antibiotic Treatment of Spirochaetal Infections

The Jarisch-Herxheimer Reaction An adverse reaction to antibiotic treatment for spirochaetal infections, the Jarisch-Herxheimer reaction is a phenomenon clinicians should…

Latest News

Swissmedic Expands Indication for Fabhalta: What You Need to Know

On February 11, 2026, Swissmedic announced the extension of the therapeutic indication for Fabhalta, a medical device used in various…

Latest News

Swissmedic Announces Benocten Tropfen zum Einnehmen Lösung Batch Recall Notice

Swissmedic has issued a batch recall notice for Benocten Tropfen zum Einnehmen Lösung, a product used in healthcare settings. The…

Latest News

Swissmedic Launches Registration for Legacy Devices

Swissmedic, the Swiss Agency for Therapeutic Products, has announced the availability of the “Legacy devices” registration system. As of February…

Latest News

Swissmedic Issues Notification for Irbesartan Spirig HC Due to Text Error on Packaging

A recent notification issued by Swissmedic, the Swiss Agency for Therapeutic Products, has brought attention to a critical issue regarding…

Latest News

Swissmedic Updates Guidelines for Medical Device Maintenance: What You Need to Know

As of January 30, 2026, Swissmedic has updated its guidelines for the maintenance of medical devices, introducing Version 2.1 of…

Latest News

Swissmedic Authorises Obgemsa: What It Means for Medical Device Manufacturers

As of 30 January 2026, Swissmedic has granted authorisation for Obgemsa, marking a significant milestone in the medical device landscape.…

Latest News

Swissmedic Authorises Alyftrek: What You Need to Know

Alyftrek Receives First Authorisation As of 30 January 2026, Alyftrek has been granted its first authorisation by Swissmedic, marking a…

Latest News

Swissmedic Intensifies Market Surveillance of Medical Devices: Key Takeaways for Importers

Swissmedic, the Swiss Agency for Therapeutic Products, has conducted a focus campaign on importers of medical devices, resulting in significant…

Latest News

Swissmedic Introduces Mandatory Quality Standards for Pharmaceuticals: What You Need to Know

The Swiss Agency for Therapeutic Products, Swissmedic, has announced a significant shift in the regulatory landscape for pharmaceuticals in Switzerland.…

Latest News

Swissmedic Approves Extension of Therapeutic Indication for Nubeqa

PUBLISHED: January 29, 2026 Swissmedic has announced the approval of an extension of therapeutic indication for Nubeqa, a significant development…

Loading more articles…
Scroll to Top