Meet the experts: navigating year-end FDA registration and listing requirements The year-end FDA registration and listing cycle can create avoidable pressure when establishment and product listing information...
Your EUDAMED readiness checklist for actor, certificate, product, and UDI data The first four EUDAMED modules became mandatory on May 28, 2026, making EUDAMED an immediate operational requirement for...
Opus Regulatory — Washington, DC | October 20 We'll be at Opus Regulatory's Global Labeling and Regulatory Symposium in Washington, DC. Come find our team to discuss how LexisNexis supports...
Regulatory Affairs Professionals Society — Charlotte, North Carolina | September 15–17 Meet us at RAPS Convergence 2026 in Charlotte — the flagship event for regulatory affairs professionals...
Informa Connect — Berlin, Germany | June 15–18 Find us at the MedTech Summit in Berlin, where regulatory affairs professionals and industry leaders tackle MDR/IVDR compliance and market access...
The first four EUDAMED modules became mandatory on May 28, 2026, making EUDAMED an immediate operational requirement for medical device manufacturers under the EU MDR and IVDR.
Organizations with incomplete actor, certificate, product, or UDI data may face costly remediation, increased regulatory scrutiny, and potential disruptions to European market access. Our new whitepaper provides a practical roadmap to help you assess your readiness, address priority gaps, and establish a sustainable compliance process.
Don't wait for the next deadline to uncover gaps in your EUDAMED process.
Download the whitepaper to understand what your organization should address now to support compliance and uninterrupted access to the European market.