Unique device identification (UDI) for medical devices is getting more visibility that ever. And with upcoming compliance deadlines around the corner, more healthcare manufacturers are asking for clarity – “what is it?” and “how do I prepare?” So, let’s start with a quick overview.
What Is It?
A UDI is a system used to mark and identify medical devices within the healthcare supply chain. It was implemented to help improve patient safety by solving traceability challenges such as product recalls and counterfeit devices.
UDI regulation was first instituted in the United States by the FDA. This regulation grouped devices into three risk classifications (Class III, Class II, Class I) and required medical device manufacturers to submit UDI information about their products to the GUDID (Global Unique Device Identification Database) – a central repository of device information intended for public access by healthcare providers and clinicians.
Suppliers of Class III and Class II devices in the US have already had to meet submission deadlines. Class I manufacturers are preparing for this requirement as the next compliance date is in September 2020.
How Do I Prepare?
Have you identified the scope of Class II products impacted?
Is your data sourced from multiple locations?
Is your data accurate and complete?
Do you have a formal data governance strategy?
Do you have a sustainable process to provide accurate product information to the FDA?
Do you have a primary source of product information truth?
If you’ve answered ‘No’ to any of these questions, it’s time to establish a primary source of product information to ensure the information you share with the FDA is trusted and accurate. We also suggest you tune in to our upcoming LIVE webinar, TOMORROW, May 8th at 11am ET featuring Arthrex, a leading orthopedic medical manufacturer. They’ll be speaking with folks from Innovit and 1WorldSync to outline the steps needed to prepare and validate medical device product information before the September compliance deadline.