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A look at the EU’s new Unique Device Identification system

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One of the central tenets of the European Parliament's new medical device regulations is the implementation of a Unique Device Identification system. (Photograph: symbiot/Shutterstock)
Dental Tribune International

By Dental Tribune International

Thu. 1. February 2018

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BRUSSELS, Belgium: In April 2017, the European Parliament voted to approve new medical device regulations to improve safety in the medical and dental industry within the European Union (EU). One of the central tenets of the new regulations is the implementation of a Unique Device Identification (UDI) system that corresponds with the European Database on Medical Devices, a publically accessible and comprehensive database of medical devices, by May 2020.

The new ISO EN 13485:2016 UDI system will allow for the identification and tracking of medical devices across the European supply and distribution chain. Dental manufacturers and distributors have been preparing for the changes that the system will bring by familiarising themselves with the new regulations; ensuring their existing business relationships are brought up to standard; and conducting internal assessments to guarantee their own compliance.

What is a UDI system?
A UDI is a series of alphanumeric characters that is assigned to either the device or the device packaging. It is printed in both plain text and in a format that is machine-readable and consists of two parts: a device identifier and a production identifier. The idea of a UDI system is not only specific to the EU—the U.S. Food and Drug Administration is currently creating its own database based on UDI-specific legislation, while the UK’s National Health Service formulated its own version in 2014.

What are the benefits?
A UDI system aims to present numerous benefits for both patients and dental dealers alike. It allows for improved traceability of each and every medical device sold in the EU—reducing the risk of confusion between similar products and preventing misunderstanding the correct use of a particular device—which would help with patient safety. For example, if a medical device that was used in a hospital were to become contaminated, its UDI would enable the tracking of its use on patients.

For dealers and manufacturers of medical devices, one of the benefits of the UDI system is that it will lead to fewer counterfeit products and improve the handling of product recalls, thereby providing faster solutions for potential issues. In addition, more efficient tracking methods should also streamline the process of managing or monitoring inventory.

How can European dental dealers prepare?
It is important for European dental dealers to review their agreements with manufacturers to ensure they meet the requirements of the new UDI system. Of course, dealers should also conduct an internal assessment to see how they can best ensure their own compliance to the requirements after the transitional period ends, as non-compliance may not only lead to legal problems in the EU, but also prohibition on importing into the U.S.. It is therefore important that dental dealers prepare for the new regulations and keep up to date with any changes so that the transition can be as smooth as possible.

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