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Changing the Layout of Medical Device Label(s)
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Changing the Layout of Medical Device Label(s)
Changing the Layout of Medical Device Label(s)
Changing the Layout of Medical Device Label(s)
Changing the Layout of Medical Device Label(s)
Changing the Layout of Medical Device Label(s)
Changing the Layout of Medical Device Label(s)
Changing the Layout of Medical Device Label(s)
Changing the Layout of Medical Device Label(s)
Changing the Layout of Medical Device Label(s)
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Changing the Layout of Medical Device Label(s)


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labeling requirements, medical devices
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Old 11th August 2017, 04:56 AM
MDD_QNA

 
 
Total Posts: 29
Please Help! Changing the Layout of Medical Device Label(s)

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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