Australia 3G Shutdown in Oct 2024 May Impact Medical Devices
The decommissioning of 3G networks in favor of more advanced 4G and 5G networks may affect medical devices and products…
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MDCG Guidance Clarifies IVDR Product Classification and Scope
Despite over a year having passed since publication of Version 3 of the Manual on borderline and…
The Essential Guide to EU MDR Medical Device Classification
Early device classification is essential, especially if you have a complex…
MDCG Guidance on CAPA Plan Assessment for Notified Bodies
The MDCG (Medical Device Coordination Group) has released a guidance document titled “Corrective and Preventive Action (CAPA)…
EMA Launches Pilot Program for Orphan Medical Devices in EU
The European Medicines Agency (EMA) has launched a pilot program aimed at supporting manufacturers of high-risk medical…
IGJ Report Urges Medical Device Manufacturers to Prioritize PMS
The IGJ, or the National Competent Authority of the Netherlands, published a report as a call to manufacturers to focus…
EU-Swiss Medtech Industry Supports MRA Update Negotiations
A joint statement by Swiss Medtech, SVDI, and MedTech Europe highlights the industry’s support for the ongoing EU-Switzerland negotiations…
RAPS Convergence 2024: MedEnvoy Key Takeaways
From September 17th to 19th, 2024, the MedEnvoy team attended RAPS Convergence 2024. This event brought together regulatory affairs…
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Global Medical Device Classification Frameworks and Regulations
Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
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