Implant Card - Full Manufacturer's Address - Space issues

kunal9218

Starting to get Involved
#1
Hi all,
Trying to work on Implant Cards for a Class III device. My question is I am having space issues so I cannot add full manufacturer's address. Is it necessary to add full manufacturer's address?
 
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Marcelo

Inactive Registered Visitor
#2
How would you have space issues when you can use any size or solution for the card that you want (and fulfill the requirements)?

Anyway, you do need to put the manufacturer address.
 

kunal9218

Starting to get Involved
#3
Well, the company is inclined towards a particular size that they want to use. That is the reason, we cannot add the full address.
 

Marcelo

Inactive Registered Visitor
#4
I don't think it's compliant to not put required information because the company decides to use an "small" implant card. You need to give all the information, and the size has to fit that (please note that this requirement is a little different than the ones related to put information ON the device, where the size of the devices does really matter and can be used to justify putting the information somewhere else - but even in this case, you cannot NOT put the requirement information).
 
Last edited:

dgrainger

Trusted Information Resource
#5
There is European guidance on the implant card: DocsRoom - European Commission
It must show:
"information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;"​

You also need to provide a patient implant information leaflet with the remaining information required in Article 18.
 
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