UDI labeling for power module

phase90

Starting to get Involved
#1
I have a question regarding UDI labeling and external power modules. If I have a medical device that uses an external power module (60601-1 approved, DC output) for power and the module is essentially off the shelf (has different connector than standard), does it need UDI labeling on the module for the module?

For the product labeling on the module itself, would the MANUFACTURER (contact info, etc) be the company that makes the supply module or would it be the company that then provides the module with the medical device for which it is being used?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
The answer depends on:
- whether the power module is supplied with the medical device, or as part of the medical device, i.e. the sales/supply configuration (which includes packaging, supply/billing logistics, sales/marketing pitch etc. - the whole shebang)
- who assigns the power module its intended use as a medical accessory (IEC 60601 seems to imply that the original manufacturer does)
 

phase90

Starting to get Involved
#3
The supply module would be suppled to our company for use with a ME device as a power source. The OEM that makes the power supply sells it generically in distribution channels with different voltage configurations, etc. The module is slightly modified from its generic form for a specific output voltage with a unique cable/connector for the output for connection with our ME device, sold directly to us (not available for sale to others).
With that being the case, it raised questions internally on how it should be labeled and if it needs the a UDI.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
The module is slightly modified from its generic form for a specific output voltage with a unique cable/connector for the output for connection with our ME device
Who modifies it - the OEM or you?

Another question - is the context EU or USA?
 
#6
The power supply is usually a part of the insulation diagram to provide MOP to mains. Therefore it is part of 60601-1 (and emc?) tests of the ME device. Under which circumstances is the power supply then not part of the ME system?
 

phase90

Starting to get Involved
#7
The power supply is usually a part of the insulation diagram to provide MOP to mains. Therefore it is part of 60601-1 (and emc?) tests of the ME device. Under which circumstances is the power supply then not part of the ME system?
Yes, agreed that it is tested as part of the system for 60601-1 and EMC. I am still unclear on the labeling on the external power module itself.
 
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