List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EEC

How do you handle this requirement?

  • Just a description of what's in the device ("Device Description")

    Votes: 0 0.0%

  • List out all the components on the label

    Votes: 0 0.0%
  • Total voters
    0
M

MutlipleHats

I am looking for some guidance interpreting EU Directive 93/42/EEC, specifically (13.3 (b)): "the details strictly necessary to identify the device and the contents of the packaging especially for the users".

Does that necessitate that a full list of contents be placed on the system kit's label? Or can the system kit label have a description of the device like "Company Name Should Stimulator System"? That identifies the device & the content within the device without listing out every thing in the BOM. Within the IFU it lists out every part included in the BOM.

What do others do, specifically when the BOM is very lengthy?
 
rob73

rob73

looking for answers
Re: List of Contents - Medical Device - Interpreting EU Directive 93/42/EEC

I think it is more to stop someone putting a description like "Hip replacement" when the contents could be from a range of "hip replacements". The correct description could be "Goodmove hip replacement kit,inc. universal femoral implant size 57 and bone screw set." this makes it clear to the user what the product contained is.
 
Ronen E

Ronen E

Problem Solver
Moderator
Re: List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EE

MutlipleHats said:
I am looking for some guidance interpreting EU Directive 93/42/EEC, specifically (13.3 (b)): "the details strictly necessary to identify the device and the contents of the packaging especially for the users".

Does that necessitate that a full list of contents be placed on the system kit's label? Or can the system kit label have a description of the device like "Company Name Should Stimulator System"? That identifies the device & the content within the device without listing out every thing in the BOM. Within the IFU it lists out every part included in the BOM.

What do others do, specifically when the BOM is very lengthy?
Click to expand...

Hello MultipleHats and welcome to the Cove :bigwave:

In my understanding the identification requirement comes down to 3 elements (not necessarily in this order, not necessarily next to each other):
1. A short generic description of the device (what it is).
2. The tradename.
3. Some unambiguous identifying code, such as the model number and version etc.

The contents requirement relates to discrete objects and their quantities. There is no requirement to list every component in the BOM, anywhere. If the device is a system or a kit it should suffice to list to BOM's top level elements.
 
somashekar

somashekar

Leader
Admin
Re: List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EE

MutlipleHats said:
I am looking for some guidance interpreting EU Directive 93/42/EEC, specifically (13.3 (b)): "the details strictly necessary to identify the device and the contents of the packaging especially for the users".

Does that necessitate that a full list of contents be placed on the system kit's label? Or can the system kit label have a description of the device like "Company Name Should Stimulator System"? That identifies the device & the content within the device without listing out every thing in the BOM. Within the IFU it lists out every part included in the BOM.

What do others do, specifically when the BOM is very lengthy?
Click to expand...
In terms of the kit, a component level breakdown is not the intent. All of the BOM that forms the kit as a single pack will be 'The xyz KIT'. When you have anything out of the kit, but within the pack like A CD, An Instruction manual, A tray, A warranty return card, Any other specific item for the user's use, etc., etc., you list them in the contents.
 
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