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srg36 replied to the topic CE TECH File Vs 510(k) submission differences in the forum EU Regulatory Basics 7 years, 6 months ago
One of the similarities between the technical file and a 510k submission is that both of these submissions must be reviewed and approved by the appropriate authorities before the company can market the device. In the case of the technical file in the EU, it is subject to review by a Notified Body, and in the case of the 510k in the US, it is reviewed by the FDA. Another important difference between the technical file and the 510k submission is that in order to compile a technical file, your device must have gone through design verification and validation, whereas a 510k can be submitted when the device has only gone through design verification (see source below).
https://www.greenlight.guru/blog/technical-file-vs-510-k-vs-design-history-file-dhf