Hello Anon,
Unfortunately the European Union used some bad terminology in calling this "Basic UDI-DI" because it gets really confusing in relation to UDI and UDI-DI. They should have called it the PFI (Product Family Identifier) or DFI (Device Family Identifier) or something like that to not make it so confusing. There is no immediate relationship between Basic UDI-DI and UDI-DI. In EUDAMED there is a relationship between the Basic UDI-DI and UDI-DI as product family to product versions - or can think of Parent to Child relationship.
A Basic UDI-DI is created internally by the company. It can be any designation - though there may be some character and length limitations depending on other uses, such as GS1 GMN number or EUDAMED field. The Basic UDI-DI is assigned to a product family, so this can be a large number of models or versions.
A UDI-DI is obtained from an Issuing Entity such as GS1 containing the company prefix and the model designation. The UDI-DI is assigned by product model or version. The only situation I would recommend using the UDI-DI as the Basic UDI-DI if the company only has one single product. But using the UDI-DI for the Basic UDI-DI for many different products will just cause you headaches in the future.
The Basic UDI-DI does not need to have the GTIN or it can, if the company so chooses.
A real world example is:
Product Family Artemis; the Basic UDI-DI for Artemis is ART123KLR10 (this is any designation I want to assign - many companies put a combination of the brand name and other identifiers).
In the Artemis product family, I have three models - 100, 200, and 300
My company prefix code is 784593
So therefore I get 3 DI for the three different models - 00119, 00120, 00121
So my 3 UDI-DI are 78459300119, 78459300120, 78458300121
As you can see the Basic UDI-DI is not the same as the UDI-DI, but now my Basic UDI-DI ART123KLR10 has 3 UDI-DIs underneath it.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Dec-2021 02:28
From: Franky Dubois
Subject: Basic UDI-DI
For the device registration a basic UDI-DI (= GMN Global Model Number) is required, next to the UDI-DI (= GTIN Global Trade Item Number).
Additional guidelines are given in the Medtech guideline.
Basic UDI-DI
The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the Eudamed database and is referenced in relevant certificates and EU declarations of conformity.
The Basic UDI-DI is the key in the device registration and has to be present on relevant documentation (eg certificates, declaration of conformity, technical documentation and summary of safety and clinical performance).
The basic UDI-Di can be created (with the checksum) on the website of GS1.
The basic UDI-DI should be mentioned at least on the following documents:
- Technical Documentation (provided to Notified Body in conformity assessment application)
- EU Declaration of Conformity
- Product Certificate
- EU Technical Documentation assessment certificate
- EU type examination certificate
- EU product verification certificate
- Certificate of Free Sale
- Summary of Safety and Clinical Performance (SSCP) for Medical Devices/ Summary of Safety and Performance (SSP) for IVDs
- Vigilance and Post-Market Surveillance Reports (auto-populated in EUDAMED if form is completed online): o Manufacturer Incident Reporting form (MIR)
- Periodic Summary Update Report (PSUR)
- Field Safety Corrective Action Reporting form (FSCAR form)
- Periodic Summary Report form (PSR)
- Trend Reporting form
- Clinical investigation forms for post-market studies
The basic UDI-DI can stay the same or can combine devices if:
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Rule
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Rule from
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the manufacturer SRN is the same
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Eudamed database design
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the MDR risk class is the same
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Eudamed database design
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the intended purpose of the device is the same
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MDCG guidance
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devices are covered under the same product certificate
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MDCG guidance
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the device only differs in minor characteristics
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UDI-DI
The UDI-DI is generated through the services of GS1.
The UDI-DI is mentioned on the label and in the Instructions for use.
It is accompanied by the PI (Product Identifier) part
The UDI-DI should be updated when:
- Name or trade name changes
- Major device version or model
- Critical warnings are changed
- The original performance changes
- The safety or intended use of the device changes
- The interpretation of the data changes
Minor software updates only need a new PI, while the DI stays the same.
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Franky Dubois
QA/RA Manager
Gent
Belgium
Original Message:
Sent: 07-Dec-2021 08:48
From: Anonymous Member
Subject: Basic UDI-DI
This message was posted by a user wishing to remain anonymous
Hi,
I am having a problem finding a specific example of what a Basic UDI-DI actually is. As part of the conversion to the MDR, the GSPR is requesting the Basic UDI-DI of our products. I have read definitions, but cannot find a real world example. GTINs are on our products and I am wondering if the Basic UDI-DI is actually in the first part of that GTIN? Can anyone shed some light on this for me? I am new to this company and the regulatory field which isn't helping.
Thanks!