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Unique Device Identification

Unique Device Identification

Unique Device Identification

UDI: A Guide to Device Identifiers

Global UDI Summary

Reed Tech UDI Solutions

Unique Device Identification (UDI) Update for South Korea

Unique Device Identification (UDI) Update for South Korea

Are UDI requirements in South Korea similar to other health regulators? The short answer is ‘not exactly’. In this episode of Reed Tech Insights, we discuss the legislation, policy, timing and data attributes involved in the South Korean Unique Device...

What is UDI-DI and BUDI-DI?

What is UDI-DI and BUDI-DI?

What is UDI-DI? UDI stands for unique device identification. When using UDI, the labels of medical devices contain a UDI that can be found and read by both people and machines. The UDI contains both numbers and letters in a particular sequence. This includes the...

UDI Labeling (Unique Device Identification): Best Practices

UDI Labeling (Unique Device Identification): Best Practices

Unique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to comply with UDI requirements for US FDA GUDID and other emerging health authorities around the globe. EU EUDAMED is underway and China’s NMPA,...

Update: EUDAMED Actor Module Now Planned for December 2020

Update: EUDAMED Actor Module Now Planned for December 2020

EU EUDAMED Update Updates continue to be issued from both the European Commission and industry concerning EUDAMED in light of the current COVID-19 pandemic. The latest information sets new expectations about the availability of modules and expected activity. The...

UDI and 21 CFR Part 11

UDI and 21 CFR Part 11

Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to...

Your Response to the FDA Class I Medical Device UDI Delay

Your Response to the FDA Class I Medical Device UDI Delay

Update on FDA Class I UDI On July 1, 2020 the U.S. Food and Drug Administration (FDA) issued a Guidance document for labelers of Class I medical devices. In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI) submissions...

Fact vs Fiction: UDI in China and Global Data Pools

Fact vs Fiction: UDI in China and Global Data Pools

Introduction The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices. The NMPA is the authoritative group that drafts laws and regulations for drugs, medical devices, and cosmetics. They also establish medical...

Fact vs Fiction: GDSN Connection

Fact vs Fiction: GDSN Connection

Author: John Lorenc, Sr. Manager Regulatory Solutions, Reed Tech Fiction:  Most global health authorities subscribe to a GDSN data pool, therefore, UDI compliance can be achieved by a standard GDSN data pool publication. Fact:  One of the largest health authorities,...

Global UDI Data Management-5 Best Practices

Global UDI Data Management-5 Best Practices

For Unique Device Identification (UDI) data management, there are some basics that medical device manufacturers should always keep top of mind. Here’s a 3 minute run-down of Five Best Practices for Global UDI Data Management.  For more information, see the...

Survey Shows Most Are Continuing Preparation for EU EUDAMED

Survey Shows Most Are Continuing Preparation for EU EUDAMED

Author: Gary Saner, Sr. Manager Information Solutions, Reed Tech   Survey Results Are you as a medical device manufacturer, in the middle of preparing for the EU Medical Device Regulation (MDR) and trying to figure out your response to the European Commission’s...

Webinar Recording: Prepare for EU and Other Global Regulators

Webinar Recording: Prepare for EU and Other Global Regulators

RAPS (Regulatory Affairs Professionals Society) hosts as Reed Tech shares their expertise on the topic of ‘Prepare for EU & Other Global Regulators’.  On the agenda: The known requirements of emerging regulatory channels and commercial UDI adopters...

EU EUDAMED Delayed-What to do now

EU EUDAMED Delayed-What to do now

Author: Gary Saner, Sr Manager Information Solutions, Reed Tech The speculation on EUDAMED timing has been addressed by the European Commission’s (EC) announcement on 30 October 2019 that EUDAMED will be delayed two years from the original date of 26 May 2020 to 26...

FDA GUDID Class I Reminder

FDA GUDID Class I Reminder

What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID?  Class I devices, and devices that have not been classified into class I, class II or class III that are required to be labeled with a...

Webinar Recording: UDI Data Management Around the Globe

Webinar Recording: UDI Data Management Around the Globe

MedTech Digital Week hosts as Reed Tech shares their expertise on the topic of ‘Unique Device Identification (UDI) Data Management Around the Globe’.  On the agenda: UDI Introduction and Global Landscape US UDI Recap EU UDI Summary Other Regulators and...

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