FDA vs. ISO 13485 - Are FDA Documents for Devices accepted in Europe

T

TamTom

Hello,

we are in the process to close one of our plants, in Europe, and in the future the basic for our dental alloys bits, will come from US, we in Germany will to the further processing and selling in Europe, for this and one other reason we are planning to get the ISO 13485 certificate in Germany. The US plant will also process and sell the alloys on the US market, know we have the discussion who will be responsible for the design history files and if US plant should get a ISo 13485 certificate.
Now my question, what is mandatory for the US plant to sell the alloys in US, and does anybody has an idea if any "approval" in US is accepted in Europe?

Does somebody know if the FDA Documents for Devices are accepted in europe?

Regards,

Tamara
 
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M

MIREGMGR

what is mandatory for the US plant to sell the alloys in US

Such alloys, as with many other medical-device-specific metallic materials, probably are indirectly regulated in that their formulation and processing must be consistent with a US standard that is recognized by the US FDA via the Recognized Consensus Standard system. The FDA doesn't require materials safety validation for materials that conform to a Recognized Consensus Standard, assuming they're used in a conventional application. I don't know the specifics of your field, but my assumption is that your potential customers will expect certified-lab verification of conformance to such a materials standard.

does anybody has an idea if any "approval" in US is accepted in Europe?

Generally, EC regs encourage conformance to standards. If the US standard is ISO, EC acceptance should be easy. If the US standard is ASTM but there is no parallel-but-different ISO standard, EC acceptance still should be straightforward. The key question will be, what standard does the US FDA recognize, and what standard do your potential EU customers normally expect?

Does somebody know if the FDA Documents for Devices are accepted in europe?

At present, generally no. There is some slow progress toward harmonization, though, at least in the opposite direction.
 
T

TamTom

Such alloys, as with many other medical-device-specific metallic materials, probably are indirectly regulated in that their formulation and processing must be consistent with a US standard that is recognized by the US FDA via the Recognized Consensus Standard system. The FDA doesn't require materials safety validation for materials that conform to a Recognized Consensus Standard, assuming they're used in a conventional application. I don't know the specifics of your field, but my assumption is that your potential customers will expect certified-lab verification of conformance to such a materials standard.



Generally, EC regs encourage conformance to standards. If the US standard is ISO, EC acceptance should be easy. If the US standard is ASTM but there is no parallel-but-different ISO standard, EC acceptance still should be straightforward. The key question will be, what standard does the US FDA recognize, and what standard do your potential EU customers normally expect?



At present, generally no. There is some slow progress toward harmonization, though, at least in the opposite direction.

Hello,

thanks, for your answer, my problem is not the alloy, the alloys are on the market (US and EU for years and released) it about the systems and the records. We have one alloy designed by us, (Rest is mostly on customer command) and we didn't know who shall keep the history file etc.

Regards,

Tamara
 
M

MIREGMGR

I guess I'm not understanding your questions, then.

In general, medical device regulatory records should be managed by the organization that is responsible for the product. If the US operation is part of the same company as the European operation, and if the company markets in the US and thereby is subject to FDA jurisdiction, it doesn't matter who holds the records...the FDA will see the entire company as unitary, and will expect it to conform to requirements on an overall basis.

To the extent that your company is a contract manufacturer as FDA defined, it may not be responsible for various aspects of regulatory compliance for those particular manufacturing activities.
 
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