And per section 12.1 (Implantable devices), "Implantable devices are generally not required to have a UDI carrier on the device itself (direct marking)".
In the US, it is not required.
For reference:
https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system"Direct marking would generally serve no purpose as long as the device remains implanted, as there would be no way to read the direct marking except in those instances where RFID technology could be built into the device."
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Anne LeBlanc
United States
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Original Message:
Sent: 20-Mar-2022 10:29
From: Assaf Yichia
Subject: UDI for single-use implantable device
Thank you Anne for your answer.
pPer section 12.2 (IMDRF/UDI WG/N48 FINAL: 2019) - The IMDRF UDI Guidance (IMDRF/WG/N7Final:2013) reusable should have a UDI Carrier on the device itself.
Is this still a requirement for reusable device? Is there any requirement for single-use device also? our market will be USA.
thanks
Assaf
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Assaf Yichia
QA Manager
Yokneam Illit
Israel
Original Message:
Sent: 20-Mar-2022 10:18
From: Anne LeBlanc
Subject: UDI for single-use implantable device
Hello Assaf
I'm not aware of any such requirement in Israel. Generally, countries that follow the IMDRF model require the UDI on the packaging where it can be read prior to the implantation, and no direct marking. (IMDRF/UDI WG/N48 FINAL: 2019)
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Anne LeBlanc
United States
Original Message:
Sent: 20-Mar-2022 02:15
From: Assaf Yichia
Subject: UDI for single-use implantable device
Hello all,
I would like to know if there is any requirement to bear a UDI barcode on an single-use implantable device (on the device itself) and not only on the package.
Any comment would be appreciated,
Thanks
Assaf Yichia
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Assaf Yichia
QA Manager
Yokneam Illit
Israel
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