Stack Of New And Revised EU MDR and IVDR Guidances In The Pipeline
The EU has published a lengthy list of new guidances to be drafted as well as existing guidance documents that need updating in the context of its MDR and IVD medtech regulations, including covering the interpretation of the Medical Device Regulation wording on “significant changes.”
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UK’s NHS Launches AI Regulation Service Specifically For Medtech Firms
The regulatory landscape for digital and AI-based products can be tough for companies and users alike to navigate. Four UK organizations have partnered up to create a service that aims to demystify complex regulatory rules around AI and digital medtech.
Increase Access To MedTech: AdvaMed’s Priorities For The 118th Congress
AdvaMed’s Medical Innovation Agenda for the 118th Congress emphasizes increased access to medical devices, from reimbursement for breakthrough devices to boosting America’s start-ups to closing the care disparities for underserved communities.
MDR Amending Regulation Officially Published And Already In Force
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.