In today’s ‘Coffee Talk’ we are chatting with Linda Morehouse, Account Executive with Reed Tech Life Sciences. Linda specializes in helping medical device manufacturers with Unique Device Identification solutions for global health authorities like US FDA, EUDAMED and others.
Linda, can you describe the top 3 UDI challenges med device companies are facing today?
Yes, I spend my workdays with questions about UDI and managing product data. It is a process. First, gain an understanding of the Health Authority requirements. Next, gather and stage data for final health authority submission. Afterwards, there are post-market activities to monitor.
Most med device teams find that the first thing with UDI is mastering the differing requirements and regulations around the globe.
Among Health Authorities, some similarities exist. However, there are a number of substantial differences in how UDI is being implemented from one Health Authority to another.
For instance, the US was the first to implement UDI collecting a total of 64 data attributes. The European Commission or EUDAMED database introduced a new concept, a tiered system hierarchy, called a Basic UDI or BUDI with an associated Device Identifier.
The Basic UDI-DI is the main access key in the database. Under the BUDI-DI, family ‘groupings’ of devices are connected. Relevant documents (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) are connected to devices with the same intended purpose, risk class and essential design and manufacturing characteristics. BUDI-DI is a database attribute only, separate from both the packaging and labeling of the device.
South Korea and China have both required additional attributes not previously collected by the US or EU. There are nuances from region to region.
Unique submission protocols exist from region to region. The US has the ESG (Electronic Submissions Gateway) AS2 connection, the EU has the AS4 e-Delivery, and South Korea and China use APIs.
These are just a few of the differences on how UDI is managed differently. This brings me to the second pain point—data management.
So, how do organizations manage and maintain their UDI data and ensure data synchronization with each Health Authority in their markets?
It is critical to implement a robust data management system for UDI compliance, especially for manufacturers who distribute a product in multiple regions. When one product updates, it is often necessary to make the required changes for each region where that product is being distributed. This can be time-consuming if companies must sign in to each Health Authority portal and make the updates. Manual entries increase the risk of errors.
Security is also a concern. Ensuring role-based permissions is ideal, so that records may only be changed by authorized users. Often, organizations have relied on systems like Excel for data management. This poses serious data accuracy and security concerns, as data attributes can be easily changed with no audit trail and data is often stored on a single individual’s hard drive.
For these reasons, many organizations are recognizing the need to store their UDI data in a data management system that not only maintains these unique data sets but also meets compliance standards such as 21 CFR Part 11 in the US and Annex 11 in the EU.
Maintaining subject matter expertise is a real challenge on resources and bandwidth. There are many detailed guidance documents to review.
For manufacturers, understanding each Health Authorities’ individual UDI requirements requires monitoring. Timelines, regulations and business rules are subject to published updates.
Additionally, sometimes specifications are open to interpretation. Documentation may be required to justify actions taken. Maintaining subject-matter expertise becomes increasingly difficult based on the number of regions where a product is marketed.
When questions arise, it can be difficult to receive a response from the Health Authority. Questions are often posed through help desk ticket or a consultant. It can take weeks to receive a response.
How would you describe the assistance that Reed Tech can lend?
Reed Tech is uniquely positioned to help mitigate each of the challenges we discussed. Our team of subject-matter experts closely monitor all global UDI regulatory requirements and is an active participant in global UDI working groups.
We have developed a robust global UDI Data Management solution that will seamlessly integrate into any internal data management platform. It allows clients to collect, validate and submit UDI data from a single repository to provide a cost-effective and sustainable global UDI strategy.
Get in touch with us — we can help you meet compliance deadlines, saving time and reducing redundancies on already limited resources.
Thanks Linda! And a reminder to visit reedtech.com for new webinars and blogs or contact us via email at [email protected].