The Staggering Number of Global UDI Requirements Demand Immediate Action in 2023
The importance of accurately managing product data is evident in healthcare. After all, most of these products have a direct impact on people’s health: Things like heart valves, ventilators, vital sign monitoring devices, surgical instruments, catheters, etc.
When you think about it, it is no wonder that government regulations for unique device identification (UDI) and compliance — with a dizzying array of requirements for listing information about healthcare products — are so stringent. Nevertheless, medical device providers must comply with UDI requirements worldwide, and many feel the pinch.
In the U.S., the UDI standard is the Global Unique Device Identification Database (GUDID). In the EU, the standard is EUDAMED, which uses an IT system established by Regulation (EU) 2107/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices and developed by the European Commission.
These regulatory requirements are constantly evolving, and there are fast-approaching deadlines for each of them that you need to keep an eye on.
In fact, at least ten regulatory agencies will publish new UDI requirements in the next five years!
According to a whitepaper published by KPMG in connection with EUDAMED, the EU standard, “nearly 48% of respondents have not yet developed a strategy because they do not fully understand the requirements. Of those with a plan, 25% would continue a manual process, while the other quarter would either leverage their existing IT infrastructure or create a new one”.
Harmonizing data across different world regions involves additional cost and effort for medical device providers. It is clear that medical device manufacturers need a single source of truth (SSOT) to manage all of these details effectively.
The goal is to ensure that data is:
- Aggregated from all the different sources of information
- Validated against the targeted regulatory requirements
- Checked for accuracy and consistency to ensure that these crucial devices meet requirements globally (e.g., 21 CFR Part 11, Annex 11, EUDAMED, GUDID, China NMPA, etc.)
Are you free to do business anywhere in the world?
Join us for a webinar, ‘Top 12 Things to Prepare for your UDI Journey’ featuring Wes Bloemker, formerly of Arthrex. In this webinar he will share his insights and lessons learned from over 25 year of experience driving organizational change for medical device companies.
Can’t attend the webinar? Download our quick guide on the Top 12 Things to Prepare for Your UDI Journey.