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Netherlands agrees use of FDA's UDI system for medical devices

The Netherlands will introduce US-style unique device identification (UDI) coding system for medical devices from next year, under the terms of a voluntary agreement between regulators, the medical sector and industry.

Towards the end of last month the government signed an agreement with healthcare providers and device manufacturers that products will carry the codes from July 1, 2018, to help identify and trace devices through the supply chain.

The published a rule in 2013 which established that UDIs should be applied to all medical devices placed on the US market. The rule said that a unique device identifier number should be assigned by the device manufacturer to each version or model of a device, in both in human-readable format and machine-readable formats.

The UDI code must include a device identifier along with one or more of the following: lot/batch number, serial number, manufacture date, expiration date and distinct identification code for human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

The Dutch Ministry of Health says it decided to use the FDA's UDI system to avoid adding complexity for manufacturers by requiring a separate system, and is the first in the EU to do so. Commentators have suggested that the action will raise the chances of more widespread adoption of the standard across the region.

UDIs are already mandated by the Medical Devices Regulation 2017/745/EU which was published on May 5 (and a related in vitro diagnostic regulation) but the Netherlands' action could speed up the implementation – which under EU rules comes into effect for all devices by May 26, 2027, according to an Emergo blog post.

The July 1 deadline next year applies to implantable devices, and in September 2018, the working group will meet again to broaden the list.


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