UDI for Medical Devices Going Global
EMERGO SUMMARY OF KEY POINTS:
- Most markets all over the world will have a system for Unique Device Identification within five years.
- It will likely be possible to have a single code on each device for all these markets.
- It is likely that those codes will be linked to different databases for each market.
- In March 2018 the European Commission will publish a guidance document on UDI under the MDR and IVDR.
Uptake of Unique Device Identification (UDI) systems in markets beyond the US is set to increase, with European regulators currently undertaking a major implementation project.
On Monday 12 February 2018 Emergo consultants attended a workshop on UDI organized by the European Commission in cooperation with MedTech Europe and the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR). The Commission explained the basics of UDI, and representatives of the International Medical Device Regulators Forum (IMDRF) and countries all over the world presented their current state of play regarding UDI. The Commission also announced that in March 2018 the European Guidance on UDI for Eudamed is expected to go public.
For now it is important to understand:
- UDI stands for Unique Device Identification. This is a numeric of alphanumeric code, human and machine readable and based on globally accepted standards, for positive identification of medical devices, up to the level of batch or serial number.
- The UDI consists of the UDI-DI for device identification of the unit of use and the UDI-PI for the production identifier. This combination of codes will assist in identification of a particular device in the distribution chain up to the level of production series.
- The UDI-DI code will be linked to a database (UDID). The UDI-PI should be kept by the economic operators and institutions using the devices. Device traceability will be assisted by the machine readable code on the label.
- The UDI is additional to other labelling requirements; it does not replace requirements regarding device name, name and address of the manufacturer, warnings, etc.
- Each level of packaging shall have its own UDI-DI for further identification of specific packages in the supply chain. Shipping containers are excluded.
- From the presentations of developments by authorities developing a UDI system for their market it became clear:
- That most markets will have a UDI system within five years;
- It will be possible to use a single UDI code in all these markets;
- But there will be different datasets linked to that code in different markets.
- This high level of standardization does not come as a surprise. All these markets, including the European Union, use the IMDRF UDI guidance document of 2013 for their own systems.
It is important for industry to pay attention to developments regarding UDI because this is rapidly developing into a world standard, and UDI will be an intrinsic part of medical device CE Marking. Emergo will of course follow developments and report on them. The European Guidance document as well as related developments will be analyzed.
Additional UDI and European medical device regulatory information from Emergo: