In the US, we are approaching the 10th anniversary of the publication of the US FDA UDI regulation (24 September 2013). The final, delayed class I device implementation deadline finally occurred last year. And though there are a few remaining issues (e.g., identification of non-sterile orthopedic implants and contact lenses), we have generally fully implemented UDI for US-distributed medical devices. Now, we are working on other activities to leverage UDI throughout the supply chain and to document UDI in patient records to support long-term safety and effectiveness.
However, after returning from the RAPS Euro Convergence conference in May, it became clear that there remains a lot of confusion and misinformation about UDI application in the EU. And though the US and EU UDI requirements are similar (as both are based on the GHTF/IMDRF UDI Guidance Documents), some important differences should also be considered. It is also important to note that, though the implementation of the MDR has been delayed (with the publication of the 2nd Amendment), the UDI timelines have not changed. That is, all MDR-compliant devices must be UDI compliant by the following deadlines – which, again, have not changed:
- implantable devices and class III devices from 26 May 2021 (Direct Mark by 2023)
- class IIa and class IIb devices from 26 May 2023 (Direct Mark by 2025) – THIS YEAR
- class I devices from 26 May 2025 (Direct Mark by 2027)
From an implementation perspective, the most critical UDI implementation issue is understanding that UDI is intended to serve two complementary but different purposes. The first and easiest to understand is the identification of a device during distribution. This means that we need to assign and apply a unique UDI to various packaging configurations (packages, cases, cartons). This allows stakeholders to scan and use this information to identify and capture information about these devices as they move through the (potentially global) supply chain up to the point of patient use. This can be used to support traceability, recalls, import control, and anti-counterfeiting. This information can also be used to support emergency/disaster preparedness, identification of substitute devices, and the development of a national stockpile – all shortcomings that became painfully clear during our global response to COVID-19.
The second purpose for UDI is the documentation of device use. This involves assigning and applying a unique UDI to the label of the individual device – or, often, even onto the device itself. This allows caregivers and patients to scan and capture information in a patient’s electronic health record (EHR) about the actual use of the device on or implanted into a patient. With this, providers and patients know which devices have been used on or in a patient – just as we know which medications patients take or have taken. Importantly, this also allows regulators, payors, caregivers, and patients to better understand the long-term safety and effectiveness of devices – and more quickly identify potential safety signals.
It is critical for device manufacturers to fully understand these dual purposes for UDI – and make appropriate decisions about UDI applications to support these various purposes. It is essential to institute the appropriate change management processes to appropriately identify changes that create the need for a new UDI, as well as changes to the data that are submitted to regulators’ UDI databases (e.g., GUDID, EUDAMED).
At USDM, we have helped over 100 medical device manufacturers with their UDI challenges. We can assess the current state of your UDI operations and help define and execute a scalable plan with interim milestones to achieve your future UDI-ready state.
The following are some of our areas of UDI expertise:
- Global UDI Regulatory & Program Planning
- QMS Revisions
- Label, DM, IFUs, Packaging Reviews & Guidance
- Data Collection, Cleaning, MDM, Maintenance & Submissions
- UDI MDM / Submission Apps Implementation & Validation & Release Management
- New Regulation / New Agency Planning & Support
Contact USDM to schedule a consultation, ensure you have the correct UDI information, and explore how we can help create a scalable plan to address your challenges.