Global UDI Update: Including FDA “Devices Not in GUDID” Letters and EU Legacy Device Extension

FREE ON-DEMAND WEBINAR
June 29, 2023

Global UDI Update: Including FDA “Devices Not in GUDID” Letters and EU Legacy Device Extension

Things keep shifting…when it comes to Unique Device Identification (UDI).

Understanding what is required by health authorities, when and by whom is critical for medical device manufacturers to stay in compliance.

Join us for an update on global regulators: what regions already require UDI or are planning UDI, what are the various UDI approaches, what are the UDI compliance target timelines.

We will also offer recommendations on how to comply with two recent FDA initiatives to improve the quality of the Global UDI Database (GUDID): a letter campaign advising Manufacturers their listed devices are not reported to the GUDID and a public notice to update GMDN codes in the GUDID.

In addition, we will provide a focused impact assessment of the recent EU Legacy Device Amendment that introduces qualifying requirements and extends the transition deadline for placing Legacy Medical Devices on the EU market.

Bring your questions as we break down the deliverables for UDI.

Watch the webinar

Specifically, this webinar will help you:

Learn about the current UDI approach taken by global Health Authorities
Get clarity on Regulation (EU) 2023/607 (Legacy Device extension)
Learn actions required to comply with the two recent U.S. FDA initiatives to improve GUDID data quality
Identify the current EU EUDAMED implementation plans and UDI/Device registration timing
Find out more about the new concepts in the MDR

Who should attend?

Regulatory Affairs Professionals & Management
Quality Professionals and Management
Medical Device Executives
Product Development Engineers and Management

Hosted by

Moderator:
Etienne Nichols

Medical Device Guru,
Greenlight Guru

Presenter:
Gary Saner

Sr. Manager, Information Solutions, Life Sciences,
Reed Tech

About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

About Reed Tech

LexisNexis Reed Tech 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 Reed Tech suite of SingleSource™️ for Medical Devices, SingleSource™️ for Drug Products, and Navigator™️ for Drug Labels) enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.

Visit their website to learn more.

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