If you sell your products to Non-European market (e.g. USA), you need to follow the regulations and requirements for this country, which means that the European requirements are not applicable here!
The procedure on the platform is very similar to the Technical Files for Europe.
We call it BASE FILES and you can create the Technical File in your account as usual with a few modifications:
Please check the requirements in your tab. As you can see, the requirements are listed only very generally.
Why is there no reference to product-specific standards in Base Files, like in extended files for the EU?
For other economic regions the legal framework is very complex and with different liabilities for you.
For the identification of further and more detailed requirements, we must at this point refer to an independent 3rd party or a service provider (e.g. testing institute based in the USA) who test products against the national requirements and standards.
Nevertheless, the attachment of these Technical Files can be useful, as you will of course also receive other proof documents, which you do not want to mix up with the proof documents for Europe.
So create your Technical File for the United States and fill in the needed documents as usual!
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