The International Medical Device Regulators Forum (IMDRF) has released a vital progress document detailing advancements under…
Category: Europe
europe updates on medical device regulation and quality.
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…
IMDRF Working Group Updates Open for Feedback: Key Regulatory Insights
The International Medical Device Regulators Forum (IMDRF) has announced the availability of updates from its Working…
Critical Updates on Field Safety Notices Issued Between 16 to 20 June 2025
The UK Government has released a detailed summary of Field Safety Notices (FSNs) issued from 16…
Building Global Capacity for Medical Device Safety: IMDRF Workshop Insights
The International Medical Device Regulators Forum (IMDRF) held a pivotal two-part workshop on 11 and 19…