Dutch Regulators to Adopt FDA’s UDI Device-Labeling System

The Dutch medical device regulator and industry officials have reached a voluntary agreement on the use of UDI codes for medical devices.

The Dutch Minister of Health signed the agreement in late June, in collaboration with healthcare providers and device distributors and manufacturers. The deal uses the FDA’s UDI system as a template. Under the agreement, Dutch hospitals will exclusively use the UDI system to identify and trace medical devices, making the Netherlands the first European Union member state to agree to the system.

Data requirements for Dutch signatories will be the same as under the FDA’s system. Going forward, however, Dutch regulators may amend the requirements to better conform to the UDI regulations other EU nations develop.