Technical File
As a manufacturer or importer, it is your responsibility to produce up a technical file or technical documentation whenever you are placing a new product in the EU market.
A technical file or technical documentation is a set of documents that contains all of the relevant information of a specific product, and is aimed at demonstrating compliance with the directive/s applicable to it.
You must ensure that the technical documentation is made available to the market surveillance authorities as soon as the product is placed on the market. In addition, the technical documentation must be kept for 10 years from the date the product is placed on the market.
i-Comply can provide you with a fully integrated service that allows you to focus on your core business while we do all the work on your behalf.
By working in close cooperation with your team and your suppliers, we collect and review the needed documentation, drawing up a complete technical file that, at your discretion, can be kept available on our secure cloud server or stored on your system.
To learn more about our technical file solution, contact us.
