New MHRA Guidance on Clinical Investigations Notifications
On 27 August 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released an updated set of flow charts…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 46–54 of 657
FDA Guidance on PCCP AI-Enabled Medical Devices
On August 18, 2025, the FDA issued final guidance for industry on how to include a…
New Medical Device Approval: Regulatory COFEPRIS Reforms
On August 22, 2025, as part of the new COFEPRIS regulatory reforms, the authority issued a new agreement concerning medical…
MDCG Issues Master UDI-DI EU Guidance for Contact Lenses
Today, the EU published an updated revision of the Medical Device Coordination Group (MDCG) Guidance document…
EUDAMED: A Guide for Medical Device and IVD Manufacturers
The Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostics Regulation 2017/746 (IVDR) introduced the requirement for a new…
Swissmedic Rolls Out New Swissdamed UDI Devices Module
Swissmedic has unveiled a significant enhancement to the Swiss database for medical devices, Swissdamed, with the launch of its UDI…
MedEnvoy at RAPS Convergence 2025
We are excited to share that MedEnvoy will be participating in RAPS Convergence 2025 as an exhibitor! This year’s conference…
Digital Scribes: TGA Guidance Overview
The Therapeutic Goods Administration (TGA) has published guidance on the regulation of digital scribes, also known…
New AI Insights in EU Healthcare: Opportunities & Challenges
Healthcare systems are facing a rising demand due to aging populations, an increase in chronic and complex conditions, growing costs,…
Showing 46–54 of 657