Sam Lazzara
Trusted Information Resource
On 2017-09-07, GS1 introduced something new (I think) - Global Model Numbers (GMN). The detailed requirements are provided in the recently published GS1 General Specifications (Release 18, Ratified Jan 2018).
Here is some information from Release 18:
Background in GS1 Change Notice 17-000103
With the approval by the European Parliament on 5 April 2017, new medical device regulations for both general and in-vitro diagnostic devices are helping to advance the unique device identification (UDI) system in Europe. A new standard is needed to enable the implementation of the Basic UDI-DI for medical device companies worldwide and, as a result, allow them to use GS1 standards for UDI in Europe. The design needs to include the flexibility to allow additional industry sectors to potentially leverage this solution in the future.
I expect the implications of GMNs and further requirements will be revealed as the EUDAMED is rolled out.
Here is some information from Release 18:
- The GMN includes the GS1 Company Prefix and a Model Reference.
- The GMN Application Identifier is (8013).
- The GMN is also referred to as BUDI-DI, or Basic UDI-DI.
- The GMN is distinct and different than the UDI-DI (GTIN).
- Many UDI-DIs can be associated with a single GMN (BUDI-DI).
- For medical devices, the GMN SHALL NOT be used in any labelling, physical marking, or GS1 AIDC data carrier on associated trade items.
Background in GS1 Change Notice 17-000103
With the approval by the European Parliament on 5 April 2017, new medical device regulations for both general and in-vitro diagnostic devices are helping to advance the unique device identification (UDI) system in Europe. A new standard is needed to enable the implementation of the Basic UDI-DI for medical device companies worldwide and, as a result, allow them to use GS1 standards for UDI in Europe. The design needs to include the flexibility to allow additional industry sectors to potentially leverage this solution in the future.
I expect the implications of GMNs and further requirements will be revealed as the EUDAMED is rolled out.