Basic UDI-DI / GMN规则——GS1 General Specifications

dersh2010 · 发表于 2021-3-24 20:44:14

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GS1_General_Specifications P516.pdf (8.18 MB, 下载次数: 262)

dersh2010 · 发表于 2021-3-24 20:58:19

2.6.13 Global Model Number (GMN)
Application description
The GS1 Global Model Number (GMN) is the GS1 identification key used to identify a product model
or product family based on attributes common to the model or family as defined by industry or
regulation. The GMN comprises the GS1 Company Prefix, a model reference and check character
pair. The model reference utilises characters from GS1 AI encodable character set 82 and its
structure is left to the discretion of the brand owner who assigns it. (see section 3.9.13)
This GS1 identification key, once assigned to one product model or product family, SHALL NOT be
reissued to another. The GMN SHALL NOT be used to identify a trade item.
The Global Model Number can be used by any industry but for regulated healthcare medical devices
the following applies:
Regulated healthcare medical devices
For regulated healthcare medical devices, the GMN is the GS1 identification key to support the
implementation of the Basic UDI-DI requirements.
For regulated healthcare medical devices, the Basic UDI-DI serves as the key element in the UDI
regulatory database for medical devices.
By providing an identifier for a medical device product family, the GMN will link medical device trade
item(s) identified by GTIN(s) in the UDI database to pre-market and post-market activities (e.g.,
certificates, declaration of conformity, vigilance, market surveillance and clinical investigations).
The following points highlight the relationship between Basic UDI-DI (GMN) and UDI-DI (GTIN.)
■ Basic UDI-DI (GMN) is used for medical device registration and is assigned independent of
packaging/labelling and is different from the identifier for trade items in the supply chain (UDIDI(GTIN)).
■ All Basic UDI-DI (GMN) level attributes (in the UDI regulatory database) are common for all
GTINs associated with it.
■ All attributes across all UDI-DIs (GTINs) associated with one Basic UDI-DI (GMN) may not be
common.
■ The Basic UDI-DI (GMN) is used for device registration in the registration database. The UDI-DI
(GTIN) is used for trade item identification in the UDI database. UDI-DI (GTIN) and Basic UDIDI (GMN)
allocation may occur before, in parallel, or after each other and attribution and/or
linkage between the entities is only possible once both entities exist. For this reason, allocation
of UDI-DI (GTIN) and Basic UDI-DI (GMN) shall be made independent of one another.
■ Brand owners are responsible for the assignment of Basic UDI-DI (GMN) and UDI-DI (GTIN.)
。。。。。。

dersh2010 · 发表于 2021-3-24 21:07:59

3.9.13 Global Model Number (GMN): AI (8013)
The GS1 Application Identifier (8013) indicates that the GS1 Application Identifier data field contains
a GMN (Global Model Number). The GMN is used for the unique identification of a product model or
product family.
Note: This element string SHALL never be used to identify the entity as a trade item.
The GS1 Company Prefix (see section 1.4.4) is allocated by GS1 Member Organisations to the brand
owner that allocates the GMN. It makes the number unique worldwide. For product model or product
family other than regulated healthcare medical devices, the GMN can be used in any labelling,
physical marking, or GS1 AIDC data carrier on associated trade items.
The structure and content of the model reference is at the discretion of the brand owner. It may
contain all characters listed in figure 7.11-1.
The check character pair is explained in section 7.9.5. Its verification, which must be carried out in
the application software, ensures that the identifier is correctly composed.
The total length of the GMN including the check characters SHALL not exceed 25 characters.
Figure 3.9.13-1. Format of the element string

When indicating this element string in the non-HRI text section, the following data title SHOULD be
used: GMN
Regulated healthcare medical devices
For regulated healthcare medical devices, ade items.
When indicating the Basic UDI-DI (GMN) on documents or certificates, the following data title
SHOULD be used: GMN. The Application Identifier (AI) 8013 SHALL be excluded in such documents
and certificates.
For medical devices that fall under the EU regulations (see section 2.6.13).

dersh2010 · 发表于 2021-3-24 21:10:54

4.13 GMN rules
4.13.1 Allocating Global Model Numbers
Global Model Numbers can be used to identify base product designs or specifications from which
trade items are derived and/or registered. The exact method used to allocate the GMN is left to the
discretion of the brand owner. However, each GMN must be unique for each product model or
product family being identified and once assigned to one product model or product family, SHALL
NOT be reissued to identify another product model or product family.
For regulated healthcare medical devices, the following applies:
Allocation of the Basic UDI-DI (GMN) is made per the discretion of the brand owner, but in
compliance with regulatory rules.
4.13.1.1 Responsibility
The brand owner is responsible for the issuance and allocation of Global Model Numbers.
4.13.2 Information associated with Global Model Numbers
The data related to the product model or product family should be recorded and shared using the
Global Model Number as the key to the information. Examples of the type of information related to a
GMN, may include the brand, certifications obtained, sewing pattern (e.g., in apparel sector), form /
material/classification scheme (e.g., in construction sector), product line (e.g., in cosmetic
sector).The following points highlight the relationship between GMN and GTIN:
■ All GMN level attributes are common for all GTINs associated with it.
■ Additional attributes across all GTINs associated with one GMN may not be common.
If any attribute defined for a GMN changes in a way that trading partners are expected to
distinguish the changed or new product model from previous/current product model, a new GMN
must be assigned. Since all GMN attributes are common for all associated GTINs, this also implies
the change of these GTINs according to guiding principle 1 of the GTIN Management Standard (see
https://www.gs1.org/1/gtinrules/en).
For regulated healthcare medical devices, the following applies:
Basic UDI-DI attributes are common for all GTINs (UDI-DIs) associated with it. The identifier can be
attributed to GTINs (UDI-DIs) associated with it, in the UDI database (e.g., EUDAMED).

dersh2010 · 发表于 2021-3-24 21:12:21

蜗牛_6 · 发表于 2021-3-25 12:51:14

谢谢分享！

raimi1225 · 发表于 2021-3-26 11:41:04

感谢分享！！！

dragonich · 发表于 2021-4-6 09:11:30

谢谢楼主分享

风吹过的街道1 · 发表于 2021-7-8 13:27:02

感谢分享！！

微信t4gv4e4z · 发表于 2021-7-21 09:57:13

请问，basic UDI 生成后需要在欧盟的EUDMED或者那个机构进行注册么？？