Are there rules for when changes to a device require a new UDI?

Generally speaking, the rules of the Issuing Agencies/Entities apply, but in case of conflicting principles, the regulations prevail. Please refer to the appropriate regulation(s) as needed.

Also, the International Medical Device Regulators Forum states in section 8.4 of the UDI System Application Guide (http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-udi-sag.pdf) that any change of one of the following UDID data elements determines the need for a new UDI-DI:

a. Brand Name;

b. Device version or model

c. Clinical Size (including Volume, Length, Gauge, and Diameter)

d. Labeled as single-use

e. Packaged sterile

f. Need for sterilization before use

g. Quantity of devices provided in a package

h. Critical warnings or contraindications: e.g. containing latex or Bis (2-Ethylhexyl) phthalate (DEHP).

It also adds that new packaging configurations require a new UDI-DI. These principles should be followed as a harmonisation basis by regulators worldwide when developing UDI requirements.

For information on Healthcare, GTIN Allocation Rules visit our website -- https://www.gs1.org/standards/gs1-healthcare-gtin-allocation-rules-standard/current-standard#1-Introduction