Unique Device Identification in the EU & Beyond

When the European Parliament approved the medical device regulations last month, it added a few hundred new amendments (consistent with EU politics). For the packaging community, the amendment on unique device identification (UDI) is of particular interest.

Camilla Andersson

As most of you know, a UDI is a unique code that identifies a device's model, version, etc. and is supported by an electronic system storing and processing this information.

The device industry is infamous for its slow adoption of electronic systems to keep track of medical devices. This will soon, change, however. FDA recently published its final rule on UDI. The International Medical Device Regulators Forum is working towards a global UDI system. The European Parliament also sees the need for a trans-national UDI system, and made a few changes to the medical device regulations to clarify this. (The regulations will become law if they are approved by the EU Council.)

Specifically, the European Parliament added the word "single" in the following sentence (Amendment 123): "For devices, other than custom-made and investigational devices, a single system for Unique Device Identification shall be put in place in the Union". By adding this single word in what may be the most efficient amendment of the regulations, the Parliament made clear that Europe does not need another area where multiple systems exist.

In the same amendment, the Parliament also stressed the need for a global UDI system, adding that the EU system should "be coherent if possible with the global regulatory approach for UDI in medical devices." But since a global UDI system is still a work in progress, the "global regulatory approach" is not yet clear. IMDRF's draft guidance earlier this year gives some recommendations, but as Emergo Group reports on its website: "The organization has kept its recommendations broad enough to allow some flexibility among national regulators to pursue their own UDI frameworks."

Now when EU and FDA are creating their own systems, could this slow down progress instead of encouraging it?

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By Camilla Andersson, Freelance Journalist

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