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…
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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,…
UDI Registration in Swissdamed: Key Insights and Deadlines
With economic operator registration in the Actor module of Swissmedic’s Swissdamed database in force for Swiss…
Swissmedic Guidance Regarding System & Procedure Packs
Swissmedic has issued a new guidance document outlining the obligations for the assembly and labelling of systems and procedure…
New EU Regulation on eIFUs Adopted by Swissmedic
Swissmedic has adopted EU Commission Implementing Regulation (EU) 2025/1234, which extends the scope of electronic instructions…
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