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Recent Blogs
EUDAMED Rollout Delay: What It Means for Medical Device Manufacturers
The European Commission (EC) has missed a key milestone in the rollout of EUDAMED, the central database for medical devices in the EU. According to the previously published timeline, EUDAMED was expected to be declared “fully functional” by July 1, 2025. However, with that date now passed and no notice published in the Official Journal of the European Union (OJEU), the official timeline remains unmet.
Regulatory Survival Guide: FAQs Every Drug and Medical Device Manufacturer Should Know
Navigating drug and device regulations isn’t optional—it’s mission-critical. This Regulatory Survival Guide breaks down the complexities of global compliance, from FDA and EU MDR to Health Canada, UDI, and MoCRA. Whether you’re managing submissions or facing upcoming deadlines, use this FAQ to decode key terms, avoid costly risks, and stay ahead with expert-backed solutions like Compliance-as-a-Service (CaaS).
Reflecting on RAPS Euro Convergence 2025: Regulatory Innovation in Motion
Global supply chain shifts can jeopardize regulatory labeling. Learn how LexisNexis Reed Tech helps manufacturers stay compliant through agile, localized labeling solutions.
Shifting Manufacturing? Don’t Let Tariffs Disrupt Your Labeling Compliance
Global supply chain shifts can jeopardize regulatory labeling. Learn how LexisNexis Reed Tech helps manufacturers stay compliant through agile, localized labeling solutions.
ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know
As part of ongoing enhancements to streamline data exchange and compliance processes, the ESG NextGen platform is preparing to go live this spring. We’re sharing a quick overview of the key milestones and what they mean for you especially as we approach the submission blackout period from April 12 to April 14, 2025.
Health Canada’s Progress on Implementing the XML Product Monograph Requirement
Health Canada continues to make strides in modernizing the way pharmaceutical product information is structured and shared. As part of its digital transformation efforts, the agency is advancing the implementation of the XML Product Monograph (XML-PM) requirement, which is set to enhance efficiency, accessibility, and interoperability of drug labeling information across the industry.