Netherlands Adopts US FDA-based UDI System for Medical Devices

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and Drug Administration’s Unique Device Identification (UDI) system.

According to the post, Dutch hospitals agreed to use UDI codes exclusively for identification and traceability of medical devices, and industry promised to place only UDI codes on device labels. According to the Emergo post, this means that every manufacturer that wants their devices used in Dutch hospitals now needs to provide UDI codes on those devices.

An article from Securing Industry cites to the the Dutch Ministry of Health as saying that the decision to use the FDA’s UDI system was made to avoid adding complexity for manufacturers by requiring a separate system. According to the article, the Netherlands is the first in the EU to adopt the FDA’s UDI system, a decision that some believe may increase the chances of the UDI system being adopted elsewhere in the region.

In 2013, the US published the rule requiring UDI codes to be assigned by device manufacturers to each version or model of a device. Under the published rule, the codes must be in both human and machine readable formats. According to the FDA, implementation of UDI codes improves patient safety, modernizes device postmarket surveillance, and facilitates medical device innovation.