Even though the European version of the unique device identification regulation was introduced almost four years after the U.S. UDI rule, it stands to broaden the value of the rule with the expanded coverage for implantable devices and the requirement related to generation of real world evidence on the performance of medical devices. Since the U.S. Food and Drug Administration (FDA) UDI rule was introduced, similar mandates have been included in the U.S but only went into effect this year.
In a recent bylined article, Karen Conway looked at how the expanded requirements from Europe can broaden the value of the U.S. FDA UDI rule. Following are a few highlights from the article.
While the U.S. rule focuses more on identifying a device through distribution and use, the European regulation goes beyond that to facilitate traceability of medical devices. UDIs are the foundation of building traceability but without hospitals active participation, there can be no success. Hospital capture of UDIs is critical for all of the other benefits — adverse event reporting, recall management, improved supply chain efficiencies and post market surveillance —to come to fruition.
Another difference between U.S. and European regulations are the latter’s requirements on generating clinical evidence on medical devices across their entire lifecycle with the purpose to verify the safety, performance and clinical benefits of the device when used as intended. In the U.S., one hospital has already taken this approach, going beyond medical device data capture to all products used in the perioperative environment to identify variation and track true cost for delivery care.
In other regions of the world, including China, South Korea, Saudi Arabia and India, regulators are also working on their own versions of UDI, with the potential use of UDI in areas such as import control and reimbursement. On the whole, all of this activity could impact how UDI is seen and used in the United States, if not by government bodies, then certainly by hospitals, clinicians and commercial payors.
It is possible that we will see more parallels in UDI regulations globally with European and U.S. regulators working together closely, seeking more harmonization in regulations. The benefit of global harmonization of UDI goes beyond easing compliance with regulations. A more standardized approach to product identification benefits providers and patients as well. In a global economy, the data generated in one part of the world can be relevant for data consumers elsewhere.
Read more from Karen here.