UDI best practice

UDI is going global. Are you ready?

Susan Gosnell Medical Devices Leave a Comment

A recent Emergo blog summarized a workshop held by the European Commission earlier this month where it was revealed that most markets worldwide will have a system for Unique Device Identification (UDI) within the next five years. Based on the presentations by the various medical device authorities, the current thinking is that it will be possible to use a single UDI code in all of these markets, but that there will be different datasets linked to that code in different markets. It’s also clear that UDI will be an additional labeling requirement, to be added on top of whatever regional or local labeling requirements are in place in any given country.

This announcement of standardization on UDI doesn’t come as a surprise. Traceability is top of the priority list for every medical device regulatory body, and it makes sense to build on the work that has already been done within UDI to achieve this goal. Standardizing on UDI also makes life easier for medical device manufacturers (MDMs) operating in multiple markets, as it means you only have to build a compliant process once, and then you can extend it to all the markets following that standard.

Can your labeling benefit from standardization? 

We have long advocated the opportunity UDI compliance affords to digitally transform labeling. Now that UDI is going global, the business case for digitally transforming your labeling is even more compelling. Digital transformation is about standardizing on a single platform for label design, management and printing. It involves replacing fragmented, disparate label printing solutions, with hard-coded, printer or customer-specific templates with universal templates that can work across printers, customers, languages and markets.

Standardize to increase operational efficiency

Standardization reduces complexity and increases agility. For example, you only need to train your staff on one system. This makes you less dependent on specialized knowledge and gives you greater flexibility in how you manage label production. Standardization means reduction in template variations, which saves valuable time in maintenance. By centralizing these universal label templates in one database, you simplify processing change requests, be they from customers or regulatory authorities, because you only have to implement them in one place. A standardized process is easier to improve and to extend to third party suppliers. And the visibility that comes with standardization will make it easier to trace errors and produce reports for audits.

If you haven’t begun the process of digitally transforming your labeling, there’s no time like the present. Read more about how to start that process here.

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