Real Example of a currently marketed Procedure Pack

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robert.beck

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#1
#1
I have a question about the labeling of procedure packs that can be best answered by looking at an existing procedure pack. Can someone direct me to or towards one that has these characteristics:
1) consists of two of more components that are CE-marked themselves.​
2) at least two of the components are manufactured by distinct manufacturers. In other words, this procedure pack has items made by different companies as part of it.​
​
I am trying to understand the regulatory basis for having or not having a CE Mark on the procedure pack itself. So far, I have found this MHRA guidance from 2016:
Guidance on Legislation, Borderlines with Medical Devices (found at https://assets.publishing.service.g...e/521458/Borderlines_with_medical_devices.pdf), which states in section 19, article 12: "the kit or procedure pack itself does not need to carry an additional CE mark"
If possible, I'd like to find an EU document that supports or goes against this statement, but I'm more interested in locating an existing procedure pack that is on the market so we can see what has been done.

There is a more recent EU guidance with a similar title (Manual on Borderline and Classification in the Community regulatory framework for medical Devices), but this guidance does not mention procedure packs.
 

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Jean_B

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#2
#2
We have procedure packs. Sometimes some of the products are not ours. We don't change anything from the base products (including sterilization configuration, as they're already sterilized pre-packing. If you still take such an action that might be where it becomes your product and thus CE, as you're changing the product's manner of conforming to essential requirements (by additional processing for risk management) and thus the previous DoC may become unapplicable). Thus if only trivial packing, no CE on pack, do need to include each product's IFU if available.
Issues might also occur if your procedure pack is configured for usability considerations, but that is a less clear cut case.
 
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