6 Rules To Effectively Implement A Compliant UDI Program
By Christopher Wilson and Paul Arhanic, PwC
By Paul Arhanic and Christopher Wilson, PwC
The first and second Unique Device Identification (UDI) compliance dates have passed, and for those firms with a fair amount of Class III and implantable, life-supporting, or life-sustaining devices, preparing for UDI compliance was likely no small task. Like most new regulations, successfully understanding the difference between the “letter of the law” and the “spirit of the law” not only ensures compliance, but also determines that your UDI solution was right for your firm. Having helped several clients navigate through UDI compliance implementation, we have been able to identify several key considerations for firms embarking on a UDI compliance program for Class I and II devices.
1 − Accurately Establish The Full Scope Of Work
One of the first activities in any UDI implementation effort is to appropriately assess your business against UDI needs and define the scope of effort. This includes:
- Collecting relevant information for all medical devices marketed in the United States – This represents the initial working list of medical devices that need to be tracked for UDI compliance. Include medical devices produced in other countries if they are also sold in the United States.
- Identifying products subject to Direct Marking (DM) requirements – Remember, devices that are intended to be reprocessed before reuse are subject to DM requirements (see 21 CFR 801.45). Identifying these products is critical, because the level of effort and the timelines associated with direct marking can be longer than those associated with UDI compliance for labeling and packaging changes.
- Identifying UDI labeling and DM exceptions – These exceptions are defined by 21 CFR 801.30 (for labeling) and 21 CFR 801.45(d) (for DM). Understanding which exceptions are applicable and the rationale for their use will refine the scope of effort for UDI compliance.
- Understanding device attribute data sources for the Global Unique Device Identification Database (GUDID) submission – Part of the initial UDI compliance program implementation will likely include a large effort to identify sources for GUDID-attribute data.
Understanding the full scope of work will enable medical device manufacturers to appropriately define project needs, such as the resources and capital required to achieve full compliance by the established UDI compliance dates.
2 – Effectively Manage Your Attribute Sources
As mentioned earlier, GUDID compliance requires manufacturers to understand data sources for all device attributes. However, ensuring sustainable compliance to GUDID requirements is more than just entering the appropriate data into the GUDID at the appropriate time. It is also about controlling all sources of data that go into the GUDID, and managing the data for the entire life cycle of your devices. Much of the information published in the GUDID cannot be edited and, in some cases, any needed changes require the creation a completely new UDI record. Therefore, the veracity of your sources is paramount to UDI compliance.
3 – Effectively Manage Your Existing Product Inventory
Because each device class has a different UDI compliance date, the vast majority of major medical device companies will, at some point, have a mixture of UDI compliant and non-UDI compliant devices in the field. Understanding this information for each lot of product allows companies to accurately ascertain compliance against UDI regulations, and to appropriately manage the three-year exception for finished devices manufactured and labeled prior to their respective compliance date.
4 – Don’t Forget About Conforming Amendment Requirements
Labeling and GUDID requirements are core to the UDI regulations but, for complete compliance, it’s necessary to address conforming amendment needs. While most UDI changes in the conforming amendments seem minor in nature, relative to labeling and GUDID requirements, implementation of compliant processes and IT solutions may be a major undertaking.
5 – Balance Regulatory vs. Customer Needs
Implementing a UDI compliance program will invariably impact downstream stakeholders (i.e., customers). Whether it’s a hospital system that uses barcodes to re-order a medical device, or a third-party manufacturer that is producing on behalf the medical device company, medical device manufacturers must ensure downstream change management activities are included as a key part of implementation planning. This includes early communication to the stakeholders detailing the impact the UDI implementation timeline will have on the medical device company, and any potential relevant impact to the stakeholder. Open a dialogue with stakeholders that are essential to the strategic efforts of the medical device company, and ensure that your UDI implementation planning includes marketing and legal input to understand both customer expectations and relevant binding agreements with those customers.
6 – Address Original Equipment Manufacturer (OEM) And Contract Manufacturer (CM) Requirements
UDI compliance is more than ensuring compliance within the four walls of your business: Efforts to establish labeler responsibilities between your third-party associates are required to ensure total compliance. All devices manufacturers, big or small, produce some finished devices in collaboration with a third party. Whether you are a contract manufacturer for a third party, or a third party is a contract manufacturer for you, it is important to accurately define the labeler (as defined by the UDI regulation) and come to an agreement with your third party. This “handshake” will ensure that no products fall through the cracks during your UDI compliance efforts.
Unfortunately, this task can be cumbersome, because the FDA definition of a labeler is somewhat ambiguous. Succinctly, the labeler is the entity who causes the label to be applied. Applying this definition in a third-party situation compounds the difficulty of assigning labeler responsibilities: Who is the labeler when a product manufacturer collaborates with a third party? The best place to start is by identifying which entity owns the design of label. This entity typically is responsible for development of the product (including the label) and dictates label contents (including UDI). While some exceptions apply, it is recommended that companies use this criteria to help guide discussions with the appropriate third parties.
Conclusion
UDI compliance is more than just updating labels and submitting GUDID data. Understanding the nuances will preserve the integrity of a comprehensive and compliant UDI program. Navigating through this path requires an open and collaborative environment, manifested by an active cross-functional support team. This environment, coupled with strong program management, will ensure an efficient, coordinated effort across multiple project tracks (i.e., corporate process development, operation implementation, vendor management, etc.).
About The Authors
Christopher Wilson is a manager in PwC's medical device advisory practice out of Chicago. His focus areas are strategy, quality/regulatory, and operations. He also has his RAPS RAC (U.S.) and APICS CPIM certifications.
Paul Arhanic is a director in PwC's health industries advisory practice out of Florham Park, NJ, and co-leads PwC's UDI service offering. His focus areas are supply chain, quality/regulatory, and operations.