Regulatory agencies all over the world are beginning to or already have adopted Unique Device Identification (UDI) requirements for medical devices. The global shift means medical device manufacturers need to start thinking about how they are going to tackle the identification challenges from a global perspective. Below are our most popular UDI related insights in the medical device community.
How to Ensure You Are Ready for the FDA UDI Class I Deadline
The US UDI compliance deadline for class I devices is less than four months away. Will your company be ready to comply with the regulation?
EUDAMED and Labeling Requirements for EU MDR Compliance
For many medical device manufacturers, there is still some uncertainty about what data needs to be submitted to the European Database on Medical Devices.
Challenges with UDI During COVID-19 Pandemic
The “UDI System” is not working – at least not in the way it was designed or that many had hoped for.
Most Misunderstood and Misapplied UDI Requirements
One of the most misunderstood and misapplied requirements with respect to UDI is related to the Direct Marking (DM) requirement.
US UDI Class I Medical Device Compliance Toolkit
This Toolkit is created specifically for class I companies that need to meet the regulatory requirements of the US UDI Final Rule for September 2020. The Toolkit would also be valuable for manufacturers that have established controls for Class II and/or Class III devices and have a class I site not yet compliant.