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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

EUDAMED Actor Module Release by MDR Date of Application

EUDAMED Actor Module Release by MDR Date of Application

New Approach Outline for the Continued Development of EUDAMED On Friday, March 13th, the Medical Device Coordination Group (MCDG) published a new guidance document titled: ‘Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)’....

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...

Video – US FDA GUDID Class I Reminders

Video – US FDA GUDID Class I Reminders

What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID? The deadline for 2020 is fast approaching.  Class I devices, and devices that have not been classified into class I, class II or class...

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...

Reed Tech Insights Series – US FDA and EU EUDAMED Comparisons

Reed Tech Insights Series – US FDA and EU EUDAMED Comparisons

Are data elements for EU EUDAMED similar to US FDA for unique device identification (UDI) submission? The short answer is, ‘not exactly.’ In this series of Reed Tech Insights, we take a deep-dive into the UDI data attributes of US and EU in specific areas,...

A Closer Look at FDA Convenience Kits: Which Need UDI? Which Don’t?

A Closer Look at FDA Convenience Kits: Which Need UDI? Which Don’t?

Pop quiz: For the purposes of FDA Unique Device Identification (UDI), is an anterior cruciate ligament (ACL) procedure kit considered one medical device, i.e., a “convenience kit?” That question is one of many addressed by the FDA’s final guidance on Unique Device...

How My True-Life Medical Device Story Includes UDI

How My True-Life Medical Device Story Includes UDI

Authors: Maura Gouak, Sales Development Representative & Angela Alexandrow, Marketing Manager, Life Sciences A member of our Life Sciences team, Maura Gouak, told us about her recent experiences with a medical device. In February, she was involved in a serious car...

Video: EU UDI – Q&A with Gary and John

Video: EU UDI – Q&A with Gary and John

If you are looking for useful desktop references concerning EU UDI, you have come to the right place. Reed Tech recently hosted a webinar discussion that included insights on what is currently known about EUDAMED requirements. The speakers covered detailed slides on...

Reference Doc: FDA & EU UDI Data Elements List

Reference Doc: FDA & EU UDI Data Elements List

Are you tracking all the news about the latest developments for EUDAMED requirements? We are too! We continue to add insights concerning what to expect as EU UDI/EUDAMED requirements are published. For your quick reference and documentation, we have created a list of...

Blog: 3 Ways to Simplify UDI and GDSN Data Management

Blog: 3 Ways to Simplify UDI and GDSN Data Management

Tracking and Tracing Medical Devices: 3 Ways to Simplify Your UDI and GDSN Data Management By: John Lorenc, Senior Manager Regulatory Solutions — Life Sciences Reed Tech The challenge of tracking medical devices throughout the health care supply chain and delivery...

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