Regulatory Open Forum

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

Your understanding is not complete.

In the GS1 system the Basic UDI-DI has three parts:
A manufacturer's number assigned by GS1
A family number assigned by the device manufacturer
Check digits calculated by a GS1 algorithm

You, as the manufacturer, build the Basic UDI-DI from these pieces.

Remember that the Basic UDI-DI is for the device family and is is different from the UDI-DI which is for the device itself.

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The requirement for the Basic UDI-DI comes from the EU-MDR, not from GS1. All four agencies have a method for the Basic UDI-DI.

I know of no reason why the Basic UDI-DI and UDI-DI must have the same company prefix. In your situation, I would expect a mixture inside the same family. Moreover, if you were to also involve another issuing agency, I don't see any reason why the Basic UDI-DI and the UDI-DI have to come from the same agency.

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The establishment of a UDI-DI system has four steps:

1. Establish a working relationship with an Issuing Agency (GS1) that is accepted by all countries.
2. Develop a standardized system to create the UDI, which includes a process to generate the UDI in new product releases, a process for existing products, creating a barcode template.   If it's a liner barcode it needs to be concatenated, this is a requirement for some countries. However, it is not a requirement for the US or EU. Therefore, a 2D barcode is better specially for a device that has product labels with space constraints.
3. Place the UDI on the label. A verification and validation process should be performed the first time to ensure that the barcode reads the DI and PI information. The barcode has to be in AIDC format and Human Readable Information (HRI) format. The UDI is required to be on the Finished Device product label, in same cases it can be on the device depending on the space available on the labels. The UDI information is not required to be on the outer box or container.
4. The final step is to create and maintain a UDI database. Many countries have their own database, for example: US- GUDID, EU- EUDAMED, Australia- ausUDID, Japan- MEDIS-DC, Turkey – TITUBB & Importer (UTS), India- Portal of Central Gov, etc.,

There are 10 countries that have UDI requirements: US, Turkey, Taiwan, South Korea, China, India, EU, Saudi Arabia, Australia, and Japan. The deadline for the UDI implantation it depends on the product classification.

 The UDI numbering system is the same for all the countries above. GS1 provides the DI, which includes the company location and the product identification. This is not the same as the reference number assigned by the companies.

The basic-UDI-DI is supposed to identify the device or a group of devices.  is supposed to provide it by EUDAMED. This number is supposed to be provided when entering information into EUDAMED and it supposed to be entered into the Declaration of Conformity for each product. The basic-UDI-DI does not need to be on the product labels.

Also, the single registration number (SRN) is a code assigned to a manufacturer, Authorized Representative etc., This code is used to register company's devices in EUDAMED database and to be able to submit assessments to the Notified Body. 

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The establishment of a UDI-DI system has four steps:

1. Establish a working relationship with an Issuing Agency (GS1) that is accepted by all countries.
2. Develop a standardized system to create the UDI, which includes a process to generate the UDI in new product releases, a process for existing products, creating a barcode template.   If it's a liner barcode it needs to be concatenated, this is a requirement for some countries. However, it is not a requirement for the US or EU. Therefore, a 2D barcode is better specially for a device that has product labels with space constraints.
3. Place the UDI on the label. A verification and validation process should be performed the first time to ensure that the barcode reads the DI and PI information. The barcode has to be in AIDC format and Human Readable Information (HRI) format. The UDI is required to be on the Finished Device product label, in same cases it can be on the device depending on the space available on the labels. The UDI information is not required to be on the outer box or container.
4. The final step is to create and maintain a UDI database. Many countries have their own database, for example: US- GUDID, EU- EUDAMED, Australia- ausUDID, Japan- MEDIS-DC, Turkey – TITUBB & Importer (UTS), India- Portal of Central Gov, etc.,

There are 10 countries that have UDI requirements: US, Turkey, Taiwan, South Korea, China, India, EU, Saudi Arabia, Australia, and Japan. The deadline for the UDI implantation it depends on the product classification.

 The UDI numbering system is the same for all the countries above. GS1 provides the DI, which includes the company location and the product identification. This is not the same as the reference number assigned by the companies.

The basic-UDI-DI is supposed to identify the device or a group of devices.  is supposed to provide it by EUDAMED. This number is supposed to be provided when entering information into EUDAMED and it supposed to be entered into the Declaration of Conformity for each product. The basic-UDI-DI does not need to be on the product labels.

Also, the single registration number (SRN) is a code assigned to a manufacturer, Authorized Representative etc., This code is used to register company's devices in EUDAMED database and to be able to submit assessments to the Notified Body. 

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

Dear Vikram,

 Let's clarify some items first.  

• The lot number is part of the PI
• Usually either the expiration date or date of manufacture is required, you don't have to have both of them. However, China requires both of them!
• The catalog number and lot number are requirements for all countries, these items and there processes are not replaced by the UDI
• The UDI is an addition to the manufacturer's process for traceability purposes to avoid or prevent injuries and to take immediate action on recalls/Field Safety Corrective Actions.
• The AIDC is a barcode format. The meaning of the AIDC is the human readable format, which is usually placed next to the barcode
• The date format used by the FDA is YYYY-MM-DD
• The UDI number usually is place on the product labels, but due to space constraints it can be placed in higher labels. There is no requirement to have the UDI on the shipping container, but you can place it on the outer box, if needed.
• Software, the DI and PI information should be on the CD and coded in the SW, so when the user plays the CD the interface should have the DI and PI information, which includes the version of the SW.
• As far as the standards go, it depends on the agency that you select. For example: GS1 uses a data matrix that contains a special start sequence to differentiate GS1 from other ISO/IEC data matrix symbols. So, there are many choices and it is up to your company to select an agency and standards.
• Standards/Type of barcodes, this selection depends on the company's products. There are many different types. Example: GSI-128, is a high density barcode, can provide a GTIN up to 14 digits.

 Now, the lot expiration date or use by date should be identified according to the stability studies performed for your product. Let's say that your studies performed demonstrated that your product is good for 12 months. In your system you enter the lot number and the issue date of each lot produced. If you do not have a system that can trace the used by date you can easily create an Excel spreadsheet to trace the use by date.

There is no check to trace the use by date in the UDI. The UDI includes the company location and product information. The lot number is part of the Product Identifier (PI) and the UDI is not replacing any of the current company's processes. The UDI is an additional step that would help companies, regulatory agencies, and hospitals to trace the products.

I recommend you read the MDR or IVDR Regulations and the US FDA has excellent training videos/materials in their website about the UDI. Good luck!

The establishment of a UDI-DI system has four steps:

1. Establish a working relationship with an Issuing Agency (GS1) that is accepted by all countries.
2. Develop a standardized system to create the UDI, which includes a process to generate the UDI in new product releases, a process for existing products, creating a barcode template.   If it's a liner barcode it needs to be concatenated, this is a requirement for some countries. However, it is not a requirement for the US or EU. Therefore, a 2D barcode is better specially for a device that has product labels with space constraints.
3. Place the UDI on the label. A verification and validation process should be performed the first time to ensure that the barcode reads the DI and PI information. The barcode has to be in AIDC format and Human Readable Information (HRI) format. The UDI is required to be on the Finished Device product label, in same cases it can be on the device depending on the space available on the labels. The UDI information is not required to be on the outer box or container.
4. The final step is to create and maintain a UDI database. Many countries have their own database, for example: US- GUDID, EU- EUDAMED, Australia- ausUDID, Japan- MEDIS-DC, Turkey – TITUBB & Importer (UTS), India- Portal of Central Gov, etc.,

There are 10 countries that have UDI requirements: US, Turkey, Taiwan, South Korea, China, India, EU, Saudi Arabia, Australia, and Japan. The deadline for the UDI implantation it depends on the product classification.

 The UDI numbering system is the same for all the countries above. GS1 provides the DI, which includes the company location and the product identification. This is not the same as the reference number assigned by the companies.

The basic-UDI-DI is supposed to identify the device or a group of devices.  is supposed to provide it by EUDAMED. This number is supposed to be provided when entering information into EUDAMED and it supposed to be entered into the Declaration of Conformity for each product. The basic-UDI-DI does not need to be on the product labels.

Also, the single registration number (SRN) is a code assigned to a manufacturer, Authorized Representative etc., This code is used to register company's devices in EUDAMED database and to be able to submit assessments to the Notified Body. 

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

The establishment of a UDI-DI system has four steps:

1. Establish a working relationship with an Issuing Agency (GS1) that is accepted by all countries.
2. Develop a standardized system to create the UDI, which includes a process to generate the UDI in new product releases, a process for existing products, creating a barcode template.   If it's a liner barcode it needs to be concatenated, this is a requirement for some countries. However, it is not a requirement for the US or EU. Therefore, a 2D barcode is better specially for a device that has product labels with space constraints.
3. Place the UDI on the label. A verification and validation process should be performed the first time to ensure that the barcode reads the DI and PI information. The barcode has to be in AIDC format and Human Readable Information (HRI) format. The UDI is required to be on the Finished Device product label, in same cases it can be on the device depending on the space available on the labels. The UDI information is not required to be on the outer box or container.
4. The final step is to create and maintain a UDI database. Many countries have their own database, for example: US- GUDID, EU- EUDAMED, Australia- ausUDID, Japan- MEDIS-DC, Turkey – TITUBB & Importer (UTS), India- Portal of Central Gov, etc.,

There are 10 countries that have UDI requirements: US, Turkey, Taiwan, South Korea, China, India, EU, Saudi Arabia, Australia, and Japan. The deadline for the UDI implantation it depends on the product classification.

 The UDI numbering system is the same for all the countries above. GS1 provides the DI, which includes the company location and the product identification. This is not the same as the reference number assigned by the companies.

The basic-UDI-DI is supposed to identify the device or a group of devices.  is supposed to provide it by EUDAMED. This number is supposed to be provided when entering information into EUDAMED and it supposed to be entered into the Declaration of Conformity for each product. The basic-UDI-DI does not need to be on the product labels.

Also, the single registration number (SRN) is a code assigned to a manufacturer, Authorized Representative etc., This code is used to register company's devices in EUDAMED database and to be able to submit assessments to the Notified Body. 

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

• ISO 8601 DATE AND TIME FORMAT( is this US FDA specific)

1. ICCBA does not list Expiry format
2. GS1 UDI samples
3. HIBCC Expiry format  does not list Dates in UDI

The establishment of a UDI-DI system has four steps:

1. Establish a working relationship with an Issuing Agency (GS1) that is accepted by all countries.
2. Develop a standardized system to create the UDI, which includes a process to generate the UDI in new product releases, a process for existing products, creating a barcode template.   If it's a liner barcode it needs to be concatenated, this is a requirement for some countries. However, it is not a requirement for the US or EU. Therefore, a 2D barcode is better specially for a device that has product labels with space constraints.
3. Place the UDI on the label. A verification and validation process should be performed the first time to ensure that the barcode reads the DI and PI information. The barcode has to be in AIDC format and Human Readable Information (HRI) format. The UDI is required to be on the Finished Device product label, in same cases it can be on the device depending on the space available on the labels. The UDI information is not required to be on the outer box or container.
4. The final step is to create and maintain a UDI database. Many countries have their own database, for example: US- GUDID, EU- EUDAMED, Australia- ausUDID, Japan- MEDIS-DC, Turkey – TITUBB & Importer (UTS), India- Portal of Central Gov, etc.,

There are 10 countries that have UDI requirements: US, Turkey, Taiwan, South Korea, China, India, EU, Saudi Arabia, Australia, and Japan. The deadline for the UDI implantation it depends on the product classification.

 The UDI numbering system is the same for all the countries above. GS1 provides the DI, which includes the company location and the product identification. This is not the same as the reference number assigned by the companies.

The basic-UDI-DI is supposed to identify the device or a group of devices.  is supposed to provide it by EUDAMED. This number is supposed to be provided when entering information into EUDAMED and it supposed to be entered into the Declaration of Conformity for each product. The basic-UDI-DI does not need to be on the product labels.

Also, the single registration number (SRN) is a code assigned to a manufacturer, Authorized Representative etc., This code is used to register company's devices in EUDAMED database and to be able to submit assessments to the Notified Body. 

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

• ISO 8601 DATE AND TIME FORMAT( is this US FDA specific)

1. ICCBA does not list Expiry format
2. GS1 UDI samples
3. HIBCC Expiry format  does not list Dates in UDI

The establishment of a UDI-DI system has four steps:

1. Establish a working relationship with an Issuing Agency (GS1) that is accepted by all countries.
2. Develop a standardized system to create the UDI, which includes a process to generate the UDI in new product releases, a process for existing products, creating a barcode template.   If it's a liner barcode it needs to be concatenated, this is a requirement for some countries. However, it is not a requirement for the US or EU. Therefore, a 2D barcode is better specially for a device that has product labels with space constraints.
3. Place the UDI on the label. A verification and validation process should be performed the first time to ensure that the barcode reads the DI and PI information. The barcode has to be in AIDC format and Human Readable Information (HRI) format. The UDI is required to be on the Finished Device product label, in same cases it can be on the device depending on the space available on the labels. The UDI information is not required to be on the outer box or container.
4. The final step is to create and maintain a UDI database. Many countries have their own database, for example: US- GUDID, EU- EUDAMED, Australia- ausUDID, Japan- MEDIS-DC, Turkey – TITUBB & Importer (UTS), India- Portal of Central Gov, etc.,

There are 10 countries that have UDI requirements: US, Turkey, Taiwan, South Korea, China, India, EU, Saudi Arabia, Australia, and Japan. The deadline for the UDI implantation it depends on the product classification.

 The UDI numbering system is the same for all the countries above. GS1 provides the DI, which includes the company location and the product identification. This is not the same as the reference number assigned by the companies.

The basic-UDI-DI is supposed to identify the device or a group of devices.  is supposed to provide it by EUDAMED. This number is supposed to be provided when entering information into EUDAMED and it supposed to be entered into the Declaration of Conformity for each product. The basic-UDI-DI does not need to be on the product labels.

Also, the single registration number (SRN) is a code assigned to a manufacturer, Authorized Representative etc., This code is used to register company's devices in EUDAMED database and to be able to submit assessments to the Notified Body. 

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator

There are three concepts often convolved: identification, tracking, and tracing.

UDI provides identification only. By looking at the UDI-DI, for example, you can identify the device. Production identifiers, when used, can provide additional information.

The UDI cannot tell where the device has been or where it is.

The EU-MDR recitals say that UDI provides traceability but it doesn't. See recital #41.

Chapter III includes Identification and Traceability of devices, but does not include any traceability requirements. Article 25 requires economic operators to keep records of the comings and goings of devices, but does not require UDIs in the records.

Two analogies. When I buy books from Amazon, I get a tracking number so I can track the package from the warehouse. The tracking number does not provide the contents of package.

A manufacturer makes 1,000 identical devices in a lot, puts them in stock, and fills orders. All the devices have the same UDI (DI + PI), but could go to 100 different customers. Knowing the full UDI does not identify which customer received which part of the lot.

• ISO 8601 DATE AND TIME FORMAT( is this US FDA specific)

1. ICCBA does not list Expiry format
2. GS1 UDI samples
3. HIBCC Expiry format  does not list Dates in UDI

The establishment of a UDI-DI system has four steps:

1. Establish a working relationship with an Issuing Agency (GS1) that is accepted by all countries.
2. Develop a standardized system to create the UDI, which includes a process to generate the UDI in new product releases, a process for existing products, creating a barcode template.   If it's a liner barcode it needs to be concatenated, this is a requirement for some countries. However, it is not a requirement for the US or EU. Therefore, a 2D barcode is better specially for a device that has product labels with space constraints.
3. Place the UDI on the label. A verification and validation process should be performed the first time to ensure that the barcode reads the DI and PI information. The barcode has to be in AIDC format and Human Readable Information (HRI) format. The UDI is required to be on the Finished Device product label, in same cases it can be on the device depending on the space available on the labels. The UDI information is not required to be on the outer box or container.
4. The final step is to create and maintain a UDI database. Many countries have their own database, for example: US- GUDID, EU- EUDAMED, Australia- ausUDID, Japan- MEDIS-DC, Turkey – TITUBB & Importer (UTS), India- Portal of Central Gov, etc.,

There are 10 countries that have UDI requirements: US, Turkey, Taiwan, South Korea, China, India, EU, Saudi Arabia, Australia, and Japan. The deadline for the UDI implantation it depends on the product classification.

 The UDI numbering system is the same for all the countries above. GS1 provides the DI, which includes the company location and the product identification. This is not the same as the reference number assigned by the companies.

The basic-UDI-DI is supposed to identify the device or a group of devices.  is supposed to provide it by EUDAMED. This number is supposed to be provided when entering information into EUDAMED and it supposed to be entered into the Declaration of Conformity for each product. The basic-UDI-DI does not need to be on the product labels.

Also, the single registration number (SRN) is a code assigned to a manufacturer, Authorized Representative etc., This code is used to register company's devices in EUDAMED database and to be able to submit assessments to the Notified Body. 

The Basic UDI-DI (GS1 GMN) is for a device family. It is not the same as the UDI-DI (GS1 GTIN), but the concept is similar. The manufacturer assigns the model number and combines it with the company prefix and the check digits to form the GMN. GS1 has a GMN check digit calculator at https://www.gs1.org/services/check-character-calculator