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GS1 introduces Global Model Numbers for Medical Devices

#1
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:

  • 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.
 

dzurn

Starting to get Involved
#2
The GS1 standard doesn't give much guidance on how to assign the model numbers, just the basics of how it's used. I find it interesting that for med devices, the GMN must not appear on the actual product or product labeling. I had heard of it as a part of the EudaMed "UDI" database, which is why GS1 had to scramble to figure out a standard way to express it.

I'm just curious how it will eventually get incorporated into the EudaMed database, and when the manufacturers will be required to assign it for each product.

There's so many ways to assign the model numbers for a family of products, so do we go for specificity or generality? "It's a green Nissan Prius with the dark purple cloth interior, 60 mile range, with working heater" versus "It's a Ford".

How we will assign this GMN will have to come through the MDR rules, but I think they are not sure themselves.

Darryl Zurn

UPDATE: Nissan doesn't make the Prius, but I don't really care. ;)
 

duinyk

Starting to get Involved
#3
According to GS1, the Format of Basic UDI-DI (GMN) per EU regulations, the GMN Application Identifier 8013 would not be included in the EU Basic UDI? So only the Company prefix and Model reference will constitute the EU Basic UDI? And should not exceed 25 characters?

This is a little confusing
 
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