Did you know there are multiple health authorities around the globe with current or future requirements for medical...
Why You Need a UDI Specialist
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Medical Devices
Recent Blogs
How to Utilize an Authorized Representative in UDI Submissions to Health Regulators
For medical device manufacturers and distributors, UDI product data submission to Health Authorities/Regulators is a multi-step process with rules and goals, much like a ‘team sport’.
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...
Evolution of UDI: A Look Back at RAPS 2020 Euro Convergence
LexisNexis Reed Tech attended RAPS 2020 Euro Convergence – this year live and online. We were able to connect virtually and share ideas with our colleagues, customers and leading industry experts at our booth, during networking hours and through live sessions. It was great to have this opportunity as the global regulatory landscape is evolving at a rapid pace.
UDI Assignment for Spectacle Lenses & Readers in EUDAMED
Are makers of eyewear products subject to Unique Device Identification (UDI) requirements for compliance with EUDAMED?...
When is UDI required for drug-device combination products?
From the FDA point of view, there are some very nuanced rules about how UDI is applied to combination products.
Saudi Arabia (SFDA) Unique Device Identification Update for Med Device Manufacturers
Background Saudi Food and Drug Authority (SFDA) issued final “Guidance on Requirements for Unique Device...
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, South Korea and others have published guidelines. UDI is becoming integrated into medical device labeling all over the world. Medical Device manufacturers doing business globally will encounter growing regulatory complexity, while also ensuring quality, streamlined processes and cost control.
UDI and 21 CFR Part 11
Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one...