Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We as the manufacturer verify and grade the 2D direct part marked DataMatrix before we ship it out to the customer to ensure it meets the minimum requirements per GS1 Specification for UDI, a grade min 1.5. Over the lifetime of the device, the 2D DataMatrix may fade due to sterilization, cleaning, etc.  The barcode is still scannable and can decode the 2D information for the life of the product . Does this meet the requirements of the EU MDR 745/2017 Part C The UDI System, Section 4.10?

EU MDR Annex VI, Part C, Section 4.10 requires that the direct-marked UDI carrier for reusable devices which require cleaning, disinfection, sterilization or refurbishing between patient uses shall be permanent and readable throughout the intended lifetime of the device.  Accordingly, if a direct-marked 2D DataMatrix UDI carrier fades to unreadability over the lifetime of the device, then such direct-marked UDI carrier would not meet the requirements of EU MDR Annex VI, Part C, Section 4.10.

Is the barcode to which you refer an additional UDI carrier providing redundancy with the 2D DataMatrix?

Is the barcode to which you refer direct-marked on the device?

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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 07-Feb-2023 08:38
From: Anonymous Member
Subject: EU MDR 2017/745 UDI

This message was posted by a user wishing to remain anonymous

We as the manufacturer verify and grade the 2D direct part marked DataMatrix before we ship it out to the customer to ensure it meets the minimum requirements per GS1 Specification for UDI, a grade min 1.5. Over the lifetime of the device, the 2D DataMatrix may fade due to sterilization, cleaning, etc.  The barcode is still scannable and can decode the 2D information for the life of the product . Does this meet the requirements of the EU MDR 745/2017 Part C The UDI System, Section 4.10?

This message was posted by a user wishing to remain anonymous

Kevin,

The 2D DataMatrix is additional to the Human Readable. The 2D on the device could be lighter in color but a barcode scanner can still decode the information that is encoded in the 2D. Is that acceptable?

HRI will still be marked and we are completely testing to make sure that is identifiable for the life of the product.
Original Message:
Sent: 07-Feb-2023 12:07
From: Kevin Randall
Subject: EU MDR 2017/745 UDI

EU MDR Annex VI, Part C, Section 4.10 requires that the direct-marked UDI carrier for reusable devices which require cleaning, disinfection, sterilization or refurbishing between patient uses shall be permanent and readable throughout the intended lifetime of the device.  Accordingly, if a direct-marked 2D DataMatrix UDI carrier fades to unreadability over the lifetime of the device, then such direct-marked UDI carrier would not meet the requirements of EU MDR Annex VI, Part C, Section 4.10.

Is the barcode to which you refer an additional UDI carrier providing redundancy with the 2D DataMatrix?

Is the barcode to which you refer direct-marked on the device?

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 07-Feb-2023 08:38
From: Anonymous Member
Subject: EU MDR 2017/745 UDI

This message was posted by a user wishing to remain anonymous

We as the manufacturer verify and grade the 2D direct part marked DataMatrix before we ship it out to the customer to ensure it meets the minimum requirements per GS1 Specification for UDI, a grade min 1.5. Over the lifetime of the device, the 2D DataMatrix may fade due to sterilization, cleaning, etc.  The barcode is still scannable and can decode the 2D information for the life of the product . Does this meet the requirements of the EU MDR 745/2017 Part C The UDI System, Section 4.10?

My understanding is that the AIDC machine-readability of the direct-marked UDI carrier shall be maintained (i.e., be permanent and machine-readable) throughout the intended lifetime of the device.  From your latest description, it sounds like both the machine-readability (though maybe faded) and the human readability of the direct-marked UDI carrier will indeed be maintained throughout the device lifetime.  But if the machine-readability is not so maintained, then the UDI carrier would not meet the requirements of EU MDR Annex VI, Part C, Section 4.10 even if the human readability is maintained.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 08-Feb-2023 06:44
From: Anonymous Member
Subject: EU MDR 2017/745 UDI

This message was posted by a user wishing to remain anonymous

Kevin,

The 2D DataMatrix is additional to the Human Readable. The 2D on the device could be lighter in color but a barcode scanner can still decode the information that is encoded in the 2D. Is that acceptable?

HRI will still be marked and we are completely testing to make sure that is identifiable for the life of the product.
Original Message:
Sent: 07-Feb-2023 12:07
From: Kevin Randall
Subject: EU MDR 2017/745 UDI

EU MDR Annex VI, Part C, Section 4.10 requires that the direct-marked UDI carrier for reusable devices which require cleaning, disinfection, sterilization or refurbishing between patient uses shall be permanent and readable throughout the intended lifetime of the device.  Accordingly, if a direct-marked 2D DataMatrix UDI carrier fades to unreadability over the lifetime of the device, then such direct-marked UDI carrier would not meet the requirements of EU MDR Annex VI, Part C, Section 4.10.

Is the barcode to which you refer an additional UDI carrier providing redundancy with the 2D DataMatrix?

Is the barcode to which you refer direct-marked on the device?

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 07-Feb-2023 08:38
From: Anonymous Member
Subject: EU MDR 2017/745 UDI

This message was posted by a user wishing to remain anonymous

We as the manufacturer verify and grade the 2D direct part marked DataMatrix before we ship it out to the customer to ensure it meets the minimum requirements per GS1 Specification for UDI, a grade min 1.5. Over the lifetime of the device, the 2D DataMatrix may fade due to sterilization, cleaning, etc.  The barcode is still scannable and can decode the 2D information for the life of the product . Does this meet the requirements of the EU MDR 745/2017 Part C The UDI System, Section 4.10?

Hi,
Medical devices that are reusable should have a UDI Carrier on the device itself. The UDI Carrier of reusable medical
devices that require reprocessing between patient uses should be permanent and readable after reprocessing cycles for the intended life of the device.

4.10 -Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device.
The requirement of this Section shall not apply to devices in the following circumstances: (only option here is that the device cannot be marked due to any type of direct marking would interfere with the safety or performance of the device or the device cannot be directly marked because it is not technologically feasible.

If you are producing a device that can be reused from patient to patient that requires processes such as cleaning and sterilization, you should mark your UDI directly on the device. You need to make sure that this UDI is permanent and is always readable.
You will need to make sure that the UDI on the device is permanent. Considering this situation, you may need to initiate validation studies.

 

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
------------------------------

Original Message:
Sent: 07-Feb-2023 08:38
From: Anonymous Member
Subject: EU MDR 2017/745 UDI

This message was posted by a user wishing to remain anonymous

We as the manufacturer verify and grade the 2D direct part marked DataMatrix before we ship it out to the customer to ensure it meets the minimum requirements per GS1 Specification for UDI, a grade min 1.5. Over the lifetime of the device, the 2D DataMatrix may fade due to sterilization, cleaning, etc.  The barcode is still scannable and can decode the 2D information for the life of the product . Does this meet the requirements of the EU MDR 745/2017 Part C The UDI System, Section 4.10?