Keeping track of all the information required to manage your medical devices on the market is a hugely complex task, and is becoming progressively more difficult. Growth in your product portfolio means a higher volume of data to manage, tighter regulatory requirements create stricter timelines and oversight for products on the market, and more stringent demands from the regulatory authorities with regards to identifying medical devices throughout their distribution and use. This blog will explore how a regulatory information management solution can significantly help.
Let’s focus first on the demands created by the unique device identification (UDI) system. In 2014, the US Food and Drug Administration (FDA) published the final UDI rule, a system that has been introduced to make sure the end-to-end product life cycle is tracked in order to improve patient safety, enhance surveillance of devices on the market, and bolster innovation. Under the system, device labels will include a human and machine-readable UDI.
The problem for companies is with so many products on the market and so many different models or versions of those products, managing the volume of data involved and meeting the requirements is a mammoth task. The FDA, therefore, came up with a seven-year plan that phases in the mandate according to the class of product, starting with class III device products – followed by implantable, life-supporting, and life-sustaining devices – followed by class II products, which are lower-risk products, and finally class I products, which are low-risk products such as dental floss.
The UDI specification requires companies to submit around 60 data attributes about each of their medical devices, which involves a substantial amount of work. Companies can either submit the information manually through the FDA’s Global Unique Device Identification Database (GUDID) or do an electronic submission, using regulatory information management system software, to GUDID.
While a seven-year plan may seem like a lot of time to prepare, for those medical devices companies with class III products UDI is already mandatory in all regards, and class II products will also soon have to adhere to the UDI requirements. This is made even more complicated because each version of a product requires a distinct DI, and that is further multiplied by the number of versions or models, manufacturer, which very quickly means the numbers for DI which is static part of UDI, can spiral out of control. (See graphic below).
UDI submission is not one time but governed by change management process, which means the manufacturers of medical devices need to track the historical data submitted to FDA.
Furthermore, while the FDA is currently the only regulatory authority to mandate the use of UDIs, other health authorities, such as the European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency, will likely follow suit in the future.
Gaining the Upper Hand with a Regulatory Information Management Solution
The problems with manual entry are many-fold. It’s impossible to track the information or to manage the review, approval and quality management process using manual processes or basic, non-integrated databases. That makes it difficult to have full control over the data that is captured and submitted to the health authority.
Adopting a regulatory information management solution will not only give companies better control over the submission process, but will also make it easier to deal with future change management issues and will make it easier to stay on top of product lifecycle management.
The ability to track medical device registrations also will give companies better oversight of their global product registrations, and support other business cases, including commercialization and managing product volume growth. In my next blog, I’ll delve into these important business aspects in greater depth.
Learn more about how ArisGlobal’s cloud-based regulatory information management solution can help you manage UDI requirements.