UDI and Product Data
This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices to manage medical device product data for established and newly formed Health Authority UDI mandates around the world.
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...
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...
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...
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,...
Vision Expo West and Eyewear Industry UDI
Reed Tech Life Sciences representative Patti Shragher attended The Vision Expo West 2022 conference, on...
Combination Products: Regulatory Requirements and How To Comply
Combination Products continue to be at the forefront of regulatory chatter. Our customers, both medical device and...
Status Update for Australia TGA UDI
The Australia Therapeutic Goods Administration (TGA) has announced several updates to the go-forward plan for...
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...
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...