The European Medical Device Regulation (EU) 2017/745 introduced the Unique Device Identification system, UDI. Each device carries an identifier that links it to its manufacturer, model and, depending on the device, its lot or serial number.
For hospitals the regulation sets a concrete requirement: health institutions must store, preferably by electronic means, the UDI of the class III implantable devices they supply or receive. National rules may extend this obligation to other devices, so each organisation should check the requirements that apply in its country.
The challenge is operational
Complying on paper is not difficult. The difficulty lies in capturing the identifier reliably at the right moments: when the product is received, when it is stored and, above all, when it is implanted and linked to the patient. That happens in the operating theatre, under time pressure, with teams whose priority is the patient.
What makes it work
- A clean product master: consistent references, correct classifications and UDI data available before the product arrives.
- Capture integrated into the workflow, at reception and at the point of use, with identification technologies that do not slow the team down.
- A link between the device, the procedure and the patient episode, so that information can be found when it is needed.
Beyond compliance
Well-recorded traceability also answers everyday questions: which patients received a device affected by a safety notice, what was consumed in each procedure, which consignment items must be invoiced. The same data that meets the regulation improves management. That is the approach we take: regulation as the starting point, operational improvement as the result.