Reed Tech subject matter experts, Gary Saner, Information Solutions Senior Manager and Patti Shragher, Medical Device Senior Account Executive and Team Lead, host a webinar discussion dedicated to Unique Device Identification (UDI) requirements for health authorities...
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LexisNexis® Reed Tech and Greenlight Guru Announce Strategic Alliance to Guide Customers to Market Faster
LexisNexis® Reed Tech has teamed up with Greenlight Guru, the leading Medical Device Success Platform for medical device companies. Horsham, Pa., USA – February 24, 2022 – In response to the needs expressed by medical device manufacturers for ways to effectively...
How Does Software as a Medical Device Relate to Unique Device Identification?
Determining Software as a Medical DeviceIt is critical to first determine if the software article is a Device Component, a Device Accessory, or a Standalone Device. A Device Component is any raw material, substance, piece, part, software, firmware, labeling, or...
What is a UDI label and UDI requirements?
What is UDI?Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier (DI) and a Production Identifier (PI). UDI is specific to a device model and version of that device on the market.How Do You Create the UDI?The...
Medical Device Classifications in Global Markets and Health Authorities
When marketing medical devices around the globe, manufacturers face the significant challenge of meeting requirements of multiple regulatory agencies.An important component of achieving regulatory approval is a classification of the medical device, according to the...
FDA GUDID Class I Reminder
(This blog was updated July 22, 2022) What is the Global Unique Device Identification Database, also known as GUDID? It is a database that contains key device information submitted to the FDA, including Unique Device Identifier (UDI) product data. Within the FDA...
EU’s Requirement for Implant Cards Provides Key Information for Patients
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices, as prescribed in Article 18 of Regulation (EU) 2017/745 on medical devices. The requirement’s purpose is to give patients easy access to important...
Updated Survey Shows Most Are Continuing Preparation for EU EUDAMED
Polls conducted May 20, 2021 Survey ResultsAre you as a medical device manufacturer, in the middle of preparing for the EU Medical Device Regulation (MDR)? Many are trying to figure out their response to the European Commission's notice that the EUDAMED launch was...
China NMPA UDI and Device Registration Basics
In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation...
LexisNexis Reed Tech is proud to be recognized by the Dental Trade Alliance as a solution provider for Unique Device Identification (UDI) to U.S. FDA and other Global Health Authorities
HORSHAM, Pa., May 18, 2021 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech™), a leading provider of data management and analytics solutions for the life sciences industry, is proud to be recognized by the Dental Trade Alliance (DTA),...