Another difference between 510k submission and a technical file is that the 510K is for Class II and above in the US. Whereas the technical file is required regardless of the class of device in the EU. The path to get a device to market in EU is dependent on class, so its crucial to be able to classify your device early on. In the EU, if your product is Class I or IIa, you may be able to self-certify but you will still need authorized representatives to legally represent your product at market.

As mentioned in lecture, Authorized Representatives must reside in the EU, only need one per company, act as the contact point for the CAs, and private companies can act as authorized reps.

https://www.greenlight.guru/blog/technical-file-vs-510-k-vs-design-history-file-dhf