UDI (Unique Device Identification) was legislated by the FDA on 24 September 2013. Device manufacturers were warned that failure to comply with UDI submission requirements would prevent them from selling products in the United States.
It’s been two years since the UDI mandate was introduced. The majority of companies who were affected by this change, that is Class III and Class II Implantables have spent a great deal of time and money implementing new labelling standards, as well as implementing PIM systems to better manage and synchronize their product information with the FDA’s GUDID (Global UDI Database).
Ultimately device manufacturers realize that the FDA’s sole purpose is to improve patient safety. Manufacturers remain positive that the system will deliver better processes internally and improve master data quality, but also externally more accurate reporting and visibility to support device recalls.
Overall, the UDI standards roll-out has seen minimal issues apart from the deadlines being extended this year for Class II Implantables from Sept 24 to Oct 24 due to technical issues with the GUDID system.
Internationally, The European Commission has already recommended that a common framework for a UDI adoption consistent with the FDA’s data standard. Industry experts are saying that China will be the next in line, planning to implement UDI standards in the near future. Will the Chinese authorities align their requirements with those of the US and EU in order to minimize costs of compliance for device manufacturers, or will they deviate and build their own system? All eyes are now on China anticipating this important decision.
Health Canada is also actively participating in the UDI framework supported by the International Medical Device Regulators Forum (IMDRF). Members of the IMDRF already include Japan, Australia, Brazil, Canada, United States, and the European Union, all working in collaboration with the FDA to align their UDI framework. Health Canada is also participating in this group, focusing on the adoption of a system that is right for their market.
At the end of the day, it’s clear that there may be more than one flavor of the UDI standard. Global device manufacturers will need to plan for this or face the loss of sales to emerging markets still in the planning stage for this system. Watch this space!
Article has been provided by Innovit
Innovit is a member of the GS1 Global Healthcare group. Innovit is also a business partner and certified solution partner of GS1 UK. Our Product Information Management (PIM) systems enable healthcare companies to adopt GS1 and UDI standards rapidly, and efficiently. Innovit software is certified for the GDSN data pools in United States, Germany, United Kingdom, Netherlands, Australia, and New Zealand.