Unique Device Identification for Medical Hardware Reaches Europe

by Laura Johnson, on April 17, 2017

Medical device label regulations
Medical device regulations have received an update in Europe.

Unique device identification (UDI) requirements are coming to Europe as part of the European Commission's latest legislation. The agreement has been in its basic stages for months now and finally emerged with numerous stipulations for companies in the industry. Manufacturers should take note that the EU will now employ a revised identification process to ensure many varieties of medical technology are traceable through their life cycles.

"Tighter rules around traceability are designed as consumer assurances."

Feeling the need for new rules
In the European Commission announcement of the revisions, the legislative body asserted that confidence in the industry has suffered in recent years among doctors and patients alike. Tighter rules around areas such as traceability are designed as assurances that manufacturers produce devices with sufficient oversight.

The device identification system is set to play a major part in the creation of a Europe-spanning medical device database designed to make information easily accessible and spur innovation. While the rules have been written not to disrupt production, with certificates for devices valid for three years (five for in vitro devices), producers will still have to begin working toward compliance as soon as possible.

The National Law Review stated that since the law is going into force this year, medical device supply chains have to achieve compliance by 2020 and in vitro medical device production by 2022. The source also noted that the law has been extensively checked to make sure it is consistent across all the 24 official languages used in EU legislation.

Handling UDI
Companies operating in the U.S. medtech market are already familiar with UDI requirements. These organizations know that having the right technology in place is clearly important to keep track of medical device labeling throughout the supply chain. By employing heavily automated and consistent labeling solutions, leaders can prepare their firms for the EU's rules as they roll out.

For more on Medical Device labeling check out recently released Q&A on the topic.

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Topics:Medical DevicesLife SciencesHealthcareRegulatoryLabeling