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Medical Device Final Assembly Labelling

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assembly (a "unit" made up of various parts), class ii medical device, labeling requirements, unique device identification (udi)
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  Post Number #1  
Old 29th January 2018, 06:49 AM
JoCam's Avatar

Total Posts: 208
Question Medical Device Final Assembly Labelling

Hi All,

For a class IIa medical device that consists of numerous sub-assemblies, all of which carry individual UDI 's, should the final assembly also be labelled with a UDI?

This does sound like a stupid question, but in effect would result in the outer cover of the product (which is a sub-assembly) carrying 2 labels.


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  Post Number #2  
Old 13th February 2018, 03:00 PM
Nadaabo's Avatar

Total Posts: 16
re: Medical Device Final Assembly Labelling

I'm sorry, I'm not too familiar with medical devices, however, I have been in both contract manufacturing and design manufacturing. Every sub-assembly had to be identified. In some cases bar code labels had to be used for ease of replacement of parts during servicing.

Our design team always ensures that on an enclosure or or similar that that will need to contain a label for that part as well as a final product label, we ensured that the drawing/ design calls for the sub-assembly label to be placed on the inside of the enclosure or somewhere not easily visible by someone searching for the final assembly part number.

I hope this helps a little.
  Post Number #3  
Old 21st February 2018, 04:02 AM
dgrainger's Avatar

Total Posts: 83
Re: Medical Device Final Assembly Labelling

Annex VI is your starting point.
'system or procedure pack' - 6.3
Configurable devices - 6.4
Otherwise I don't think you need to add a UDI to a component unless article 23.2 applies
Thanks to dgrainger for your informative Post and/or Attachment!

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