On October 2, 2025, Opella Healthcare UK LTD issued an urgent notification regarding a packaging error…
Category: Europe
europe updates on medical device regulation and quality.
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…
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…
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…
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…
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…
Stay Updated on Key IMDRF Updates and Consultations
The International Medical Device Regulators Forum (IMDRF) has introduced a convenient way for clinical, quality, and…
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.…
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…
Swissmedic Introduces Horizon Scanning Platform to Enhance Regulatory Oversight
Swissmedic has unveiled a new horizon scanning website to improve proactive regulatory measures. This initiative aims…