Unique Device Identification (UDI) requirements for medical devices are currently being implemented by the US FDA, and European and Japanese authorities are expected to adopt similar programs in the coming years. The new rules are intended to improve traceability of devices for post-market vigilance purposes, and will have to be met in order to obtain US market compliance. UDI compliance will require significant effort on the part of manufacturers.
Emergo has carefully followed the development of UDI rules at both the US and international level for several years, and has the expertise and resources to help medical device companies set up compliance processes to meet US FDA UDI requirements.
How the US FDA UDI system works
FDA UDI compliance involves more than just etching a number onto your medical device or adding a bar code to your label. Several components are involved:
Each UDI must can two numbers: a device identifier and a production identifier. A device identifier must correspond to the specific model or version of a medical device and the company name.A production identifier must provide a medical device’s lot or batch information or serial number, expiration date and related production data.
- Class I devices must be assigned device identifiers only. Class II and III devices must be assigned both device identifiers and product identifiers.
- Manufacturers must obtain UDI numbers only from FDA-accredited issuing agencies.
- All medical devices registered for sale in the US will have to include UDI information on their labeling and packaging.
- Devices intended for more than one use as well as devices requiring reprocessing before each use must also have UDI data marked directly on them.
- Manufacturers must provide UDI information in both plain-text (human readable) and AIDC (Automatic Identification and Capture) formats.
Manufacturers will be required to submit UDI data into a new FDA database, the Global Unique Device Identification Database (GUDID) using proper formatting.
The FDA’s UDI rules will not be fully implemented until 2020, but higher-risk devices will have to comply sooner than that.
How Emergo can support your UDI compliance efforts
Emergo has been supporting medical device companies’ FDA registration and compliance projects since 1997, and has closely monitored the development of UDI requirements in the US and other countries. We can ensure your US FDA medical device registration project includes a fully compliant UDI component through the following methods:
- Identifying appropriate FDA-accredited UDI issuing agencies on your behalf
- Providing training to educate your staff on proper UDI compliance
- Assisting you to incorporate UDI processes into your quality management and production operations
- Ensuring proper UDI data formatting for submitting to GUDID
Regardless of whether you are introducing a new medical device, or looking for assistance in assuring compliance for existing devices in your product portfolio, our FDA consultants can assist with UDI compliance and training.
For more information on our services for US FDA UDI compliance, please contact us.