Richard Pether, director at Rotech, gives an overview of UDI and some practical steps that healthcare suppliers can adopt to implement UDI using offline coding technologies.
In 2013 the US Food and Drug Administration (FDA) mandated unique device identification (UDI) for most medical devices distributed in the United States.
Supported by the International Medical Device Regulators Forum (IMDRF), regulators in the rest of the world are considering similar legislation.
International guidance on UDI has been developed, and this will serve as the basis for the EU’s future identification and traceability infrastucture, building on the pharmaceutical pack serialisation requirements set out by the Falsified Medicines Directive (FMD), which comes into force in 2018.
The ultimate aim is that there will be one, globally harmonised system for identification of medical devices – from surgical instruments, inhalers, contact lenses and dressings to diagnostic tests – by healthcare providers such as the NHS.
So, for producers and packers of healthcare products, it’s no longer a question of whether item-level serialisation will become a legislative requirement in the EU. It’s a question of when.