Changing the Layout of Medical Device Label(s)

MDD_QNA

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#1
We are planning to change the layout of your labels. Is it required to report this change to the NB?

What we are planning to do is also to box every part that is being supplied to the customer, this means that we have one big shipping box where the product is being fitted. In this big box we have smaller boxes containing different parts of the device. What is the minimal labeling requirement on these? Is it sufficient to have the name of the company, name of manufacturer, name of the part (and a picture) together with the adress and name of legal manufacturer? Is there a requirement to have the CE mark on any of the boxes?

I had found a document stating that we need to write out the weight of the package being shipped. However, I can't find that document right now and I need advice on if someone knows where to find this information (preferably) or if someone knows the requirements on when to write out the weight of any package or box? (For safety reasons of course)

Another question concerns spare parts, we have the main part which is the medical device itself and we are planning on changing our spare parts handling. So we are going to ship this part as a spare part and we haven't done this before. What is the minimal required information to supply together with this spare part? Do we need to send the IFU or can we just put in a quick guide showing how to mount the part and refer to the IFU (that they should already be having)?

This is a class IIa medical device in EU.

Thanks in advance!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

You have listed many questions in a single post. Those are not very difficult questions, however some of them are also not trivial to answer. It's not impossible that a single Cove member would know all, or most of the answers. It's also not impossible that several members together could have answered all your questions. Nevertheless, the fact is that no one replied. In my opinion the reason is that the scope of your post exceeds the "normal" extent of a public discussion forum post. It looks more like an email that a retainer consultant would receive from a client.

If I had to responsibly answer your post, it would take me more than "5 minutes", and I suspect the same applies to most members here. Hopefully I'm wrong - my reply has "bumped" this thread for another chance, and maybe someone would answer at least some of your questions, off the top of their head. If not, and you're still interested in some focused help, please feel free to PM me.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#3
We are planning to change the layout of your labels. Is it required to report this change to the NB?

What we are planning to do is also to box every part that is being supplied to the customer, this means that we have one big shipping box where the product is being fitted. In this big box we have smaller boxes containing different parts of the device. What is the minimal labeling requirement on these? Is it sufficient to have the name of the company, name of manufacturer, name of the part (and a picture) together with the adress and name of legal manufacturer? Is there a requirement to have the CE mark on any of the boxes?

I had found a document stating that we need to write out the weight of the package being shipped. However, I can't find that document right now and I need advice on if someone knows where to find this information (preferably) or if someone knows the requirements on when to write out the weight of any package or box? (For safety reasons of course)

Another question concerns spare parts, we have the main part which is the medical device itself and we are planning on changing our spare parts handling. So we are going to ship this part as a spare part and we haven't done this before. What is the minimal required information to supply together with this spare part? Do we need to send the IFU or can we just put in a quick guide showing how to mount the part and refer to the IFU (that they should already be having)?

This is a class IIa medical device in EU.

Thanks in advance!
As it is your NB who is providing you the gateway to EU, it is good to discuss any and all types of label changes with your NB. Your additional questions will also be answered in that process.
 

pkost

Trusted Information Resource
#4
We are planning to change the layout of your labels. Is it required to report this change to the NB?
What class of product? IF class III then yes, anything lower then if it is layout only, I would consider it a small change

What we are planning to do is also to box every part that is being supplied to the customer, this means that we have one big shipping box where the product is being fitted. In this big box we have smaller boxes containing different parts of the device. What is the minimal labeling requirement on these? Is it sufficient to have the name of the company, name of manufacturer, name of the part (and a picture) together with the adress and name of legal manufacturer? Is there a requirement to have the CE mark on any of the boxes?
What do you do currently? This sounds like more than just a change of label layout?....
Is this kit being put together under article 12? If so then each item would usually be considered a device in it's own right and therefore labelled appropriately.
If you are not going down the article 12 route and it is essentially an IKEA kit for your device, then the required information must be on the outer box and I would risk assess the level of information on the inner boxes; as a starter for 10 I would say the internal boxes need:
  • Item name/identifier
  • Statement that it is intended for the main product
  • manufacturer details
  • lot details
  • warning symbols e.g. keep dry

I had found a document stating that we need to write out the weight of the package being shipped. However, I can't find that document right now and I need advice on if someone knows where to find this information (preferably) or if someone knows the requirements on when to write out the weight of any package or box? (For safety reasons of course)
weight is not required by the device directive unless your risk assessment determines it should be. the weight requirement is more likely to be customer driven (I used to demand weight on outer shippers from our suppliers), the NHS may similarly require a weight indication for their health and safety requirements

You may want to take a look at directive 76/211/EEC and see if that applies (it refers to selling measured quantities e.g. buying 50ml perfume)



Another question concerns spare parts, we have the main part which is the medical device itself and we are planning on changing our spare parts handling. So we are going to ship this part as a spare part and we haven't done this before. What is the minimal required information to supply together with this spare part? Do we need to send the IFU or can we just put in a quick guide showing how to mount the part and refer to the IFU (that they should already be having)?
I'm confused by "the main part which is the medical device itself", are the other parts accessories?? in which case the directive treats them as devices in their own right.

If the main part is a medical device in its own right it should be labelled as a
 
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