Medical Devices
Proactive standards tracking helps MedTech companies stay audit-ready and globally compliant
RegDesk News/Info
On June 17, 2025, the European Commission released a significant update to MDCG 2019-11, the foundational guidance on the Qualification and Classification of Software under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
European Union
The UK’s MHRA has issued a substantial update to its Manufacturer’s Online Reporting Environment (MORE) portal, in preparation for the Post-Market Surveillance (PMS) regulatory changes that will take effect across Great Britain on June 16, 2025.
RegDesk News/Info
Regulatory intelligence refers to the continuous process of gathering, analyzing, and applying regulatory information to support compliance, accelerate approvals, and guide market entry.
Medical Devices
This article provides a detailed overview of the M11 draft which covers how clinical trial protocols are created, shared, and reviewed.
RegDesk News/Info
Artificial Intelligence (AI) is no longer emerging in healthcare, it’s here and it’s changing everything. From revolutionizing diagnostics to enabling real-time patient monitoring, AI is accelerating innovation across the MedTech landscape.
