Navigating FDA GMDN Compliance: Replacing FDA Preferred Terms and Updating Obsolete GMDN Codes

FDA GMDN compliance for medical device manufacturers Watch our on-demand webinar to learn about the FDA’s updates impacting medical device manufacturers, specifically regarding the Global Medical Device Nomenclature (GMDN) Codes in the Global Unique Device Identification Database (GUDID) . The FDA phased out Preferred Terms (PTs) as of December 17, 2024, and worked to eliminate outdated GMDN Codes, so manufacturers...

Breaking Down the EU’s Latest EUDAMED Functional Confirmation

On 2025-Nov-27 , the European Commission published a EUDAMED Functional Notice in the Official Journal of the European Union (OJEU) announcing that several major EUDAMED modules: Actors Registration UDI/Devices Notified Bodies & Certificates Market Surveillance “have achieved functionality and meet the functional specifications.” This notice marks a significant milestone toward full EUDAMED...

EUDAMED UDI Compliance: Why “Later” is Already Too Late

With the final phase of EUDAMED UDI implementation looming, the myth of “more time” is putting manufacturers at risk. The recent 3-month delay is not a grace period — it’s a wake-up call. If you haven’t already submitted to EUDAMED, you’re not just behind schedule — you’re in jeopardy of noncompliance. In this timely webinar, we’ll break down what the delay actually...

A Behind-the-Scenes Look at the Australia Regulatory Device Summit

Our team captured what mattered most—AU-specific interpretations, common reviewer questions, and practical steps to de-risk your next submission. Australia’s market is attractive—but only if you navigate TGA requirements with confidence. Fresh from the Australia Regulatory Device Summit, our attendees distilled the most useful, Australia-specific regulatory insights: how expectations are shifting,...

The State of Global Regulatory Compliance 2026:

Digital submissions, UDI expansion, and evolving regulatory expectations Regulatory frameworks worldwide are entering a new phase defined by structured data, centralized device databases, and machine-to-machine submission models. As global authorities expand UDI requirements and modernize submission infrastructure, life sciences organizations face increasing pressure to strengthen data governance, while navigating evolving...

Health Canada XML PM: What We’ve Learned Since the July 18 Deadline

The 18 July 2025 deadline for Health Canada's mandatory XML Product Monograph (PM) submissions has come and gone — but what has the transition revealed about industry readiness, process challenges, and regulator expectations? Join us for a post-deadline debrief where regulatory experts share key insights from the initial wave of XML PM submissions. We will explore common hurdles companies faced, lessons learned...

FHIR and the Future of Labeling: What You Need to Know

As regulatory authorities and health systems push toward digital transformation, Fast Healthcare Interoperability Resources (FHIR) is emerging as a key framework for enabling the exchange of health data—including product labeling information. In this webinar, experts from LexisNexis ® Life Sciences Solutions, a recognized thought leader in regulatory data standards and electronic labeling (eLabeling) , will...

LexisNexis Life Sciences Solutions & 1WorldSync – The Role of Medical Device UDI & GDSN in Regulatory Compliance Strategy

1WorldSync® is the leader in Product Content Orchestration, enabling more than 17,000 companies in over 60 countries to simplify the creation and distribution of impactful content that’s accurate, consistent, and relevant everywhere commerce happens. Through its technology platform and expert services, 1WorldSync—backed by global investment firm Battery Ventures—solves revenue-impacting product content...

Understanding Drug Reporting Requirements Under the CARES Act

The Coronavirus Aid, Relief, and Economic Security (CARES) Act introduced significant changes to the drug regulatory landscape. Among these changes are new drug reporting requirements that drug manufacturers and distributors must adhere to. LexisNexis Life Sciences subject-matter experts, Gary Saner and Andrew Ethridge, presented a webinar providing a comprehensive overview of these requirements, their implications, and...

eCTD v4.0: The Future of Regulatory Submissions

Industry is currently seeing rapid changes and improvements to existing eCTD formats, requirements and suggested uses from FDA. These and other changes affect Regulatory Operations as a whole. Here at LexisNexis Reed Tech, we want to be sure that our customers are not only up-to-date with, but understand, these new developments. To support this knowledge share, our in-house team of eCTD experts are presented a webinar...

MoCRA A-Z

MoCRA: What cosmetics companies need to know The Modernization of Cosmetics Act of 2022, commonly known as MoCRA, is changing the way cosmetics companies need to operate in the United States. This new set of FDA guidelines is the first change to cosmetic regulation requirements since 1938 — and enforcement is now in effect. We know these many regulations and deadlines can be challenging to navigate but LexisNexis...

Drug Label Research Across the Product Lifecycle

LexisNexis Life Sciences Solutions brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our suite of SingleSource ™ for Medical Devices , SingleSource ™ for Drug Products , and Navigator ™ for Drug Labels enables...