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Leveraging another company's ISO 13485:2016

#1
I couldn't seem to find the answer elsewhere. We are a U.S manufacturer producing a Class II device with 510(k) clearance and looking to get the device CE marked. Is it possible for us to fall under another company's ISO 13485: 2016 considering that we do not have one of our own? What are some of the cons to us and the other business adding us to their ISO cert? I'm curious if this is a feasible option for both sides. Initially, the customer with ISO expressed interest in CE marking a convenience kit that included our class II device. But we are hoping to CE mark the device so it can be sold to EU on our own and the customer can use it in their own kit as well.
 
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shimonv

Trusted Information Resource
#2
If you have a class II device with 510(k) clearance than you are obligation to good manufacturing practices (21 CFR 820).
For you to come under someone else's ISO certificate means that you have to adopt their QMS and "inherit" their processes with their flaws
This makes no sense. Not recommend.

Shimon
 

levatorsuperioris

Involved In Discussions
#3
No, as a legal manufacturer you need 13485 for CE marking, full stop. What flavor of 13485: EN ISO, ISO or MDSAP etc... that's up to you (if you ship to Europe alone, some jurisdictions require the EN ISO). Other jurisdictions have requirements into scope.
 

levatorsuperioris

Involved In Discussions
#4
additionally the second part of your question, it depends on how they get market access, if they are a "procedure pack" then everything in there needs CE mark itself.

If they are to get the annex 2 - CE mark, by letting them get CE mark for your product (this is possible) but you must grant them full access to all your technical documentation (give away the keys to the Kingdom) for conformity assessment and you would need a quality agreement that you would fully support their audits aka fly in.

The other method is to get CE mark yourself and they can do a OEM-PLM and get their own CE mark (but under the MDR which is in May) this is only possible when they have an agreement with full unconditional and immediate access to all your technical information (again giving away keys to the kingdom).
 
#5
If you have a class II device with 510(k) clearance than you are obligation to good manufacturing practices (21 CFR 820).
For you to come under someone else's ISO certificate means that you have to adopt their QMS and "inherit" their processes with their flaws
This makes no sense. Not recommend.

Shimon
Thanks!
 
#6
additionally the second part of your question, it depends on how they get market access, if they are a "procedure pack" then everything in there needs CE mark itself.

If they are to get the annex 2 - CE mark, by letting them get CE mark for your product (this is possible) but you must grant them full access to all your technical documentation (give away the keys to the Kingdom) for conformity assessment and you would need a quality agreement that you would fully support their audits aka fly in.

The other method is to get CE mark yourself and they can do a OEM-PLM and get their own CE mark (but under the MDR which is in May) this is only possible when they have an agreement with full unconditional and immediate access to all your technical information (again giving away keys to the kingdom).
Thanks !
 
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