If your team is planning for the coming changes related to EU MDR/IVDR labeling, and the reporting of UDI data to EUDAMED, click below to view this brief video from our ongoing vlog series-Reed Tech Insights.
Gary Saner, Sr. Manager of Information Solutions, reviews the EU MDR regulations and former directives. He also discusses key differences and similarities of FDA and EU unique device identification (UDI), timelines and what is known currently concerning requirements.
The electronic submission process and business rules carry nuances from region to region. Subject matter expertise to navigate, understand, and react are a necessity. Reed Tech specializes in understanding the deep details of submission requirements, lifting the burden on your internal resources.
Considering solutions and strategies for EU MDR? We welcome the opportunity to discuss the possibilities. Email us: MedDevice@ReedTech.com