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Recent Blogs

Why You Need a UDI Specialist
Did you know there are multiple health authorities around the globe with current or future requirements for medical...

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...

OTC Monograph Fees Announced… Not so fast!
Co-Authored by David Wilson, Sr. Account Executive, Reed Tech, and Carolina Wirth, Of Counsel, Arnall Golden Gregory,...

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?...