Netherlands to Use FDA's UDI System

The country is the first EU member state to agree to the FDA’s system.

Late last month, a voluntary agreement was reached between Dutch medical device regulators and industry officials to use the FDA’s unique device identification (UDI) coding system as a template for identification and tracing of medical devices.

Under the agreement, products will carry the codes beginning July 1, 2018, to help identify and trace devices through the supply chain between healthcare providers and device manufacturers.

Though Dutch data requirements will be the same as the FDA’s, the country’s regulators may amend requirements in the future.

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