As new, stricter rules were given the green light in Europe this month aimed at ensuring medical devices have traceability features and greater safety oversight, accrediting agency GS1 is making a call to action from stakeholders to help it work on a new identifier that has emerged from these rules.
At the start of the month, the European Parliament passed new rules on medical device regulations for both general and in-vitro diagnostic devices, which are helping to advance the unique device identification (UDI) system in Europe.
GS1, which has been an accredited issuing agency for the FDA in the US for its UDI regulation for years, has also been provisionally made one of the UDI-issuing entities for the EU.
But there's a snag: In order for it to be considered for final designation as an UDI-issuing entity, GS1 must meet specific selection criteria—one being the provision of a solution that implements the "Basic UDI-DI".
This is a new identifier, and one not seen in the FDA regs and so not commonly used by GS1, and is described in the new rules as being: "The primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity," although it is not applied physically on packaging or the devices.
GS1 says that this Basic UDI-DI assignment "must be done before the product can be submitted for market registration and approval by authorities—a step that is typically not part of the trade item supply chain."
Therefore, a new standard must be developed to enable the implementation of the Basic UDI-DI for medical device companies worldwide and, as a result, allow them to use GS1 standards for UDI in Europe.
It wants help from medical device companies and those in the supply chain to help develop this new standard and be quick about it: The new EU regulations are slated to be posted in the Official Journal by early May, with the deadline for the initial implementation step just three years for medical devices, and five for in vitro diagnostics.
And by end of July 2017, GS1 wants to have approved a standard that allows room for future use cases, if required, while "clearly documenting as a priority its applicability to the healthcare use case."
"The timing for GS1 to develop and deploy this new identifier presents a challenge, but also a unique opportunity for GS1 as it will allow GS1 to qualify as a UDI issuing entity in the EU," the company says.