Using your Manufacturer's ISO certification

#1
We have developed a class 1 medical device with our manufacture.
Can we use their ISO and put them as the manufacture with their address on the packaging etc?
I have done the technical file.
Thanks
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
The entity whose name and address appear on the labelling (packaging included) is considered the regulatory-responsible party (colloquially referred to as "the legal manufacturer"). That will make them primarily responsible for everything and leave you mostly out of the picture. The same entity would also need to own the Technical File ("own" as in have it on site, always up to date).
 

rob73

looking for answers
#4
We have developed a class 1 medical device with our manufacture.
Does this mean you have designed a device and you have a sub-contract manufacturer making the part for you?
Can we use their ISO and put them as the manufacture with their address on the packaging etc?
As Ronen has indicated,only if they are going to identified as the LEGAL manufacturer (under EU regulations)
I have done the technical file.
If you have complied the technical file, this says you are the legal manufacturer and your detail should be on the label.
Not knowing which region you are in does not help, labelling for regulatory compliance, especially for a medical devices can be complex. It would be better to post in either the FDA or EU forums with a clearer picture of who is doing what.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
If you have complied the technical file, this says you are the legal manufacturer
I beg to differ.
Who ends up being "the legal manufacturer" is a matter of either a conscious decision or a result of what is incidentally (unwittingly) put on the label.
The preparation (compilation?) of the Tech File may be outsourced or be a joint effort. Nevertheless, the regulatory-responsible party has to have a full, up to date copy at all times.
 

rob73

looking for answers
#6
The preparation (compilation?) of the Tech File may be outsourced or be a joint effort.
I agree, the post does not make it clear if the OP is a sub-contractor working for the "manufacturer" or the customer working with a sub-contract "manufacturer". Always best not to ass-u-me :)
 
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