Horsham, Pa., USA – May 25, 2023The collaboration of the leading providers of Unique Device Identification (UDI) for global health authorities and RIMS compliance platform, supports global medical device companies. LexisNexis Legal & Professional today announced,...
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Recent Blogs
EU Amendment to Extend Legacy Medical Device Transition
In recent news, the European Commission passed an extension (EU Regulation 2023/607) to the transition deadline for Legacy Medical Devices to be placed on the EU market. Here is a quick summary of recently posted information about the reasoning behind this decision...
Coffee Talk with Reed Tech – EU EUDAMED Testing Update
In the latest edition of 'Coffee Talk', Reed Tech UDI experts, Gary Saner (Sr. Manager of Information Solutions) and John Lorenc (Director Product Management, Medical Devices), discuss EU EUDAMED access connection issues, who has been affected, what scenarios had...
Medical Device Regulatory Requirements – Japanese Guidelines
This is a quick summary of the December 14, 2022 Emergo Webinar presented by Kenji Yashiro on the topic: Medical Device Regulatory Requirements-Japanese Guidelines Key Takeaways: This blog will cover just a few high-level takeaways from the presentation by Kenji...
Class I UDI Inventory Exception: What You Need to Know about FDA Compliance
With the US Class I UDI enforcement quickly approaching, you may be wondering “what about older inventory”? In 2013, the FDA granted a UDI exception for 3 years after the corresponding Compliance Date for finished medical devices manufactured and labeled without...
Vision Expo West and Eyewear Industry UDI
Reed Tech Life Sciences representative Patti Shragher attended The Vision Expo West 2022 conference, on September 14th – 17th. This year's event took place at the Venetian Convention Center & Expo in Las Vegas, Nevada. We asked a few questions about her...
Status Update for Australia TGA UDI
The Australia Therapeutic Goods Administration (TGA) has announced several updates to the go-forward plan for implementing UDI compliance News of note: • TGA has announced that they will have a similar model to the FDA, adopting some elements of the EUDAMED model• A...
FDA Class I Medical Device UDI Due December 2022
Update on FDA Class I UDI as of July 22, 2022 Final guidance has been issued by the US Food and Drug Administration (FDA) for labelers of Class I medical devices. In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI)...
HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface
Did you know? The FDA Class I deadline enforcement is occurring on December 8, 2022. Many in the medical device industry make plans to use the free FDA Web Interface based on the assumption that they don’t have enough products to warrant the use of Structured Product...
Preparing, Managing and Monitoring Medical Device UDI
In today’s ‘Coffee Talk’ we are chatting with Linda Morehouse, Account Executive with Reed Tech Life Sciences. Linda specializes in helping medical device manufacturers with Unique Device Identification solutions for global health authorities like US FDA, EUDAMED and...