We are nearing almost 3 years of the original publication of the UDI final ruling. What this means to medical device manufacturers is that we are just over a month away (September 24, 2016) for certain deadlines around Class III and Class II devices and packaging.
Class III regulations due Sept. 24th:
- UDI required devices must be labeled with permanent marking if device is intended to be used more than once
Class II regulations due Sept. 24th:
- Labels and packaging of devices must include UDI marking
- Dates on labels must be formatted properly to meet UDI compliance
- Stand-alone software must provide UDI
- Data for UDI required devices must be submitted to GUDID database
Pragmatyxs project consulting has assisted in various regulations including UDI and can help bring your company up to standards. With the compliance dates nearing please reach out to us for any needs.