Blog

How GUDID was it for you?

An examination of UDI implementation and lessons for manufacturers of Class II devices

In September 2013, the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use. By 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machine-readable form. In addition, device labellers must submit mandatory data about each device to the FDA/National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information.

The complexities of the new system mean that, for many companies, managing the transition to UDI compliance can be a challenging process that touches all parts of the organization. Critically, the implications for labeling operations are significant and require all medical device manufacturers to examine their current infrastructure and, in many cases, adapt it to enable more holistic label lifecycle management.

An industry poll of organizations involved in the first two phases of UDI implementation, conducted by PRISYM ID, has revealed just how challenging this has been. 58% of respondents described implementation as ‘difficult’ with a further 4% regarding it ‘extremely difficult’, whilst implementation caused reverberations in Manufacturing, Quality, Operations and Distribution. Likewise, UDI projects also tend to involve IT and regulatory teams, meaning that they permeate almost every department and system within an organization.

However, the poll shows unequivocally that the biggest impact of UDI implementation is typically felt in Labeling and Packaging, with 85% of respondents reporting that Labeling, Packaging & Design were affected the most.

For a copy of our white paper outlining the full findings of the poll, and how Label Lifecycle Management can help achieve compliance and ready your organization for the inevitable FDA inspection that includes UDI activities, click the button below.

Download the UDI Whitepaper

Have a look on our UDI Infographic

An examination of UDI implementation and lessons for manufacturers of Class II devices