Hello Anon,
First you would need to state which jurisdiction you are looking at because the rules are a bit different between the regions (sadly).
It may be the device needs direct marking to answer your second question, but 'requires reprocessing' would need to provide further information. In general, a device which is reprocessed, reusable, multiple use, etc., would need direct marking on the device. Again, there are some exemptions or rationales which can be generated depending on region if the direct marking would not be appropriate or available. As an example, the FDA provides guidance if the direct marking interferes with the device or could compromise safety, then it does not need to be directly on the device.
The Unique Device Identification (UDI) may be possible only including the Device Identifier (DI) - though again this really depends on the device. A rationale, risk assessment, and documenting reasons for direct marking or not direct marking would need to be performed. It also depends if this cylindrical device needs the Product Identifier (PI) in order to provide the traceability. There are a few items going on in this scenario you may need further advice.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 16-Apr-2024 15:47
From: Anonymous Member
Subject: Class I devices and UDI (DI)
This message was posted by a user wishing to remain anonymous
We are developing a Class I device which requires reprocessing and is not exempted from GMP. The device is cylindrical and it may be difficult to add the UDI directly on the device. I have 2 questions:
- Can the UDI be the DI (i.e. the GTIN) only?
- Is it necessary to directly mark this on the device?