A proposed rule issued by the FDA pertaining to the unique device identification system likely foreshadows its mandatory implementation, as it is aimed at establishing compatible traceability systems between member states of the European Union.

The unique device identifier (UDI) is a number assigned to a medical device that enables the identification of different types of devices and access to useful and relevant information stored in a UDI database.

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 was signed into law. The act sets out measures for implementing the UDI system, which will require devices to carry a unique identifier to allow identification through both use and distribution. The UDI will not be a substitution, but an addition to the existing labeling requirements for medical devices. Recently, the FDA’s proposed unique device identification system rulerule was released.

The European Commission leads an UDI Ad Hoc Working Group at the Global Harmonization Task Force (GHTF) level in order to draft recommendations and guidelines to ensure that the U.S. UDI will be globally compatible. The idea is to promote a global approach in order to avoid discrepancies between the different UDIs produced by the different GHTF/AWHP (Asia Working Harmonization Party) members.

First, the working group’s guidelines explain why a UDI system should be adopted—mainly, because it can make traceability of devices more efficient, allow easier recall of devices, fight counterfeiting, and improve patient safety.

Next, the guidelines state that a member state can establish its own UDI, if it respects some mandatory requirements (system should vary according to the risk class of devices, and the system should be implemented first for medical devices posing high risks to human health and then for other classes of medical devices).

Finally, the guidelines impose obligations on manufacturers, importers, authorized representatives, distributors, health institutions, and professional users to:

  • Comply with requirements concerning the allocation of a UDI to their medical devices,
  • Keep record of both device identifier and producer identifier
  • Not modify the UDI

Written by guest blogger Jeremy Petitprez, a student at the Paris Bar School.