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MDR Article 22: Systems and procedure packs

#1
Hi, please help me on the below confusion:
If a medical device manufacturer buys an OTS device (not intended as a medical device) and delivers to the user together with his other CE marked devices, will it be considered as "systems and procedure packs" category? Please note that there are no label changes done on the OTS. It is just for ease of customer, instead of themselves ordering directly from the OTS manufacturer we deliver as one complete set with our devices.
Meantime compatibility between the devices is verified and validated. Thanks.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
If you package them together and provide under a single brand, it may be considered a procedure pack.
If you supply as two separate products, where you only distribute (buy and on-sell without any modification of packaging or labelling) the OTS product, it's probably not a procedure pack.
 
#3
Thanks @Ronen E , we certainly are not going to distribute them under our name. The original package and label will not be touched, but if we place them together with our device in a shipping package is that going to be a problem?
Also can you please clarify, procedure packs are applicable only for medical devices or any devices? Thanks
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
Procedure packs may include items that are not considered Medical Devices in their own right.
If what you refer to as "shipping package" reaches the end-user you are walking a fine line and may be seen as supplying a procedure pack. If it's merely a wholesale packaging that's unpacked before sale to the end-user it's more "on the safe side".
 
#5
@Ronen E so got confused a little bit, you mean to say even if i just put it in the shipping pack it would be considered as a procedure pack is it?
Also, for procedure packs do i need to take care of the UDI (apart from showing evidence for mutual compatibility) as MDR suggesting that we follow section 23 of Annex I? Thanks
 

med_cert

Involved In Discussions
#6
Besides our main medical device, we have many accessories and we also use already CE marked medical devices as accessories which are classified as medical device by their manufacturers.
We can sell each accessory seperately, however we sell accessories only to be connected to our devices. We have each accessory in unique case so here there is no question regarding UDI-DI. We don't change the original packaging for "external" accessories.
We have few cases which include different accessories in the same package (few accessoreis produced by us and CE marked devices).

1. Could we say our device model including all accessory has one Basic UDI-DI and is a "system" (or maybe a procedure pack???) . And then we include all UDI-DIs (device + all accessories) under this Basic UDI-DI with many UDI-DIs? How will we be able to include those packages (mentioned above) in the EUDAMED? UDI-DIs container package will only have "quantity per package" attribute, however we will have only quantity "1" but different UDI-DIs in this package...

2. Some of our accessories can also be used with different our devices. Based on "Guidance on UDI for systems and procedure packs" "A UDI-DI shall be associated with one and only one Basic UDI-DI."... What are possibilities to implement this?
 
#7
@med_cert thanks for your response. But my only concern is - we are not considering OTS as an accessories and we dont "sell" those products directly. We claim nothing on their labels. Just as an example, if i manufacture stand alone software which can be used in any tablets, but i wish to give my customer the tablet (in its original package) together with my software in a USB stick (sales package with labels containing all details)) all packed in a shipping carton box just for transport, what category should i consider this scenario? thanks.
 

med_cert

Involved In Discussions
#8
@med_cert thanks for your response. But my only concern is - we are not considering OTS as an accessories and we dont "sell" those products directly. We claim nothing on their labels. Just as an example, if i manufacture stand alone software which can be used in any tablets, but i wish to give my customer the tablet (in its original package) together with my software in a USB stick (sales package with labels containing all details)) all packed in a shipping carton box just for transport, what category should i consider this scenario? thanks.
Hi, I apologise, I abused your thread for my question which is not connected to your question however I believed it is a similar topic as the title of this thread. I am sorry, but I don't have an answer to your quesiton.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#9
@Ronen E so got confused a little bit, you mean to say even if i just put it in the shipping pack it would be considered as a procedure pack is it?
Please read my answer carefully. There's nothing definite in it, I only highlighted some possible scenarios. It mostly boils down to how far the "shipping pack" goes - is it sold and delivered to the end-user unopened?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#10
Besides our main medical device, we have many accessories and we also use already CE marked medical devices as accessories which are classified as medical device by their manufacturers.
We can sell each accessory seperately, however we sell accessories only to be connected to our devices. We have each accessory in unique case so here there is no question regarding UDI-DI. We don't change the original packaging for "external" accessories.
We have few cases which include different accessories in the same package (few accessoreis produced by us and CE marked devices).

1. Could we say our device model including all accessory has one Basic UDI-DI and is a "system" (or maybe a procedure pack???) . And then we include all UDI-DIs (device + all accessories) under this Basic UDI-DI with many UDI-DIs? How will we be able to include those packages (mentioned above) in the EUDAMED? UDI-DIs container package will only have "quantity per package" attribute, however we will have only quantity "1" but different UDI-DIs in this package...

2. Some of our accessories can also be used with different our devices. Based on "Guidance on UDI for systems and procedure packs" "A UDI-DI shall be associated with one and only one Basic UDI-DI."... What are possibilities to implement this?
Not a 5-minute question. Please send me a PM if you'd like me to get involved.
 
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