UDI is here: Seven Things You Need to Know
Since US medical device regulators have begun implementing their Unique Device Identification (UDI) system, Emergo has identified seven key common issues to consider as you undertake UDI compliance projects.
#1. All medical devices intended to be used more than once or reprocessed before each use must have direct marking of the UDI number on the device. Implantable and single-use devices will not require the direct marking.
#2. The UDI must be on each level of packaging up to shipping and must be available to the user at all points of use.
#3. The UDI is composed of a Device Identifier (DI) and a Production Identifier (PI). The DI is supplied by an Issuing Agency and the PI includes information such as lot number, serial number, or expiration date.
#4. A firm must request a Global Unique Device Identification Database (GUDID) account on the FDA website. The applicant must fill out a form for the FDA to review before receiving account information.
#5. The FDA has specified that the date format of YYYY-MM-DD must be used for all dating on product labeling.
#6. The FDA has made it clear that all Automatic Identification and Data Capture such as bar codes can be used.
#7. The quality management system must be updated to include all of the requirements for UDI number management – including steps for obtaining the number, adding new versions/models, and discontinuing versions/models.
