Medical Device Unique Identification (UDI)

Unique Device Identification (UDI) requirements for medical devices have been implemented by the US Food and Drug Administration (FDA). The FDA issued the final Unique Device Identifier (UDI) Rule and implemented into the US Federal Register on 24 September 2013.
Manufacturers must meet UDI requirements as part of US market compliance.
UDI has impact not only on the labels, it is not only a simply barcode on the label, but it may have impact to the correct device identification on the market, and how the product could be sold and distributed.
Maytal can support the Medical device and IVD manufacturers through:
  • Gap assessments for UDI compliance, through product labelling analysis
  • UDI training and project management, working with the company staff to define how to improve UDI requirements and minimize its impact.
  • Helping to identify appropriate accredited UDI agencies on behalf of the company
  • Recording into GUDID database the products involved in UDI
  • Assisting and training the company resources to allow to properly managed GUDID database
  • Assisting the company to incorporate UDI processes into the quality management system and production operations.