Unique Device Identification Regulation

How does the UDI regulation impact your business?

The Unique Device Identification (UDI) Regulation entered into force on September 24, 2014 and applies to all medical devices sold and marketed in the United States. To device manufacturers selling and marketing products to the United States, including manufacturers exporting to the United States, it means modified workflows and new needs for data handling.  Below is the FDA UDI compliance dates:                

FDA UDI Compliance Deadlines for Medical Device Manufacturers

September 24, 2014: Class III devices & Class III stand-alone software

September 24, 2015: Implants, Life supporting, Life sustaining & stand alone software

September 24, 2016: Class II devices & Class II stand-alone software

September 24, 2018: Class I devices, Unclassified devices & Class I stand alone software

How can Tox Regulatory Advisor support your UDI compliance efforts?

Our UDI consultants can help you navigate the requirements, plan and execute the changes necessary to comply with the UDI regulation. As well assisting you to incorporate UDI processes into your quality management and production operations

Further information regarding services, expertise and how our experience can support your business; please contact us at +4526709648, Email: info@toxregulatoryaffairs.com