Do you comply with UDI?

If you supply medical devices anywhere in the world, chances are you have to comply with strict regulations – and some are pretty daunting to say the least

Here we talk about Unique Device Identification (UDI) regulations in Europe and in the US.

If you supply medical devices into other global markets, get in touch with us and talk to one of our standards experts. After all, one of the many advantages of being a global standards organisation means we can draw on local knowledge – the world over.

What is UDI?

Essentially, it’s the ability to uniquely identify, track and trace individual medical devices through the supply chain and, importantly, into a patient pathway. It goes without question this can fundamentally improve patient safety and it even enables the ability to remove an unsafe or recalled product from harm’s way before it reaches a patient.

To help achieve this industry ambition, the EU and the US have both published UDI regulations for medical devices. These regulations join a globally harmonised framework for identification of medical devices – enhancing quality of care, patient safety and business processes. Although, they do take similar but different regulatory approaches, with different compliance timescales and different databases for manufacturers to update. This means added complexity and lots of hard work for all involved.