As requirements for unique device identification (UDI) as specified by the U.S. Food and Drug Administration (FDA) enter their latter stages, UDI activity in the European Union is just ramping up.
This version of UDI is part of the Medical Device Regulation (MDR) document, and will be harmonized with GS1’s global standards, which are also accredited with the U.S. FDA.
As is the case in the U.S., UDI can be leveraged to help improve asset tracking and traceability for both internal and external supply chain and asset optimization activities. That creates value far beyond simple regulatory compliance. According to this article at MedTech Intelligence, one global device manufacturer said that label standardization via UDI reduced duplicate items/SKUs by 15%.
Xerafy offers UDI-compliant RFID solutions for medical devices, including durable, autoclavable RFID tags that can be used for identifying and tracking surgical instruments and other devices in a hospital setting.
UDI compliance was the subject of a recent conference in Brussels in May focused on applying lessons learned from the FDA implementation in the U.S. to European companies. In addition, the GS1 conference in Berlin in April featured a number of helpful UDI sessions that you can access here.
One particularly helpful sessions led by bioMerieux outlined the steps necessary for compliance.
Stakeholders have until May 2020 to comply with the MDR/UDI requirements or risk losing their CE-mark certification or access to the EU market for their devices. To prepare, manufacturers should:
* Evaluate their product portfolio to see which products fall under MDR, or whether those products have had a classification change
* Ensure those products are compliant with the new requirements both in terms of labeling and performance/clinical evidence documentation.
* Evaluate your existing data quality, and establish a method of creating a single, central source of accurate product data.
* Establish a process to review your labeling, make adjustments to meet the new requirements, and then ensure that the new labels are properly deployed across each class of device.
* Prepare to submit data to the EUDAMED database in Europe. UDI data will be exchangeable between EUDAMEND and the GUDID database in the U.S.
* Investigate your labeling options. Will there be size limitations? Can you correctly print the necessary labels? Can using RFID (or a combination of RFID and barcodes) improve the labeling process or provide downstream benefits?
* Start early. There will be as much as four years’ of transition time after the initial deadline, but all products must comply with the MDR; changes made to pre-MDR products after the deadline can create additional challenges for manufacturers.
Are you affected by the EU’s new UDI requirements? Xerafy’s RFID solutions can help you meet UDI requirements in both the U.S. and in Europe. Contact us with your labeling compliance questions here.