Tech File is required regardless of the class of device in the EU, whereas in the US the FDA requires a 510(k)for Class II and higher. Another difference is the Tech File as Dr. Simon mentioned in lecture, it has a set format. This format is referred to as the Summary Technical Documentation (STED). The STED format was created by the Global Harmonization Task Force (GHTF) know known as the International Medical Device Regulators Forum (IMDRF), in an effort to standardize medical device regulatory submissions on a global scale. The US, EU, Canada, Australia and Japan are currently either actively using STED or evaluating the format under pilot programs. Canadian regulators recommend STED formatting for Class III and IV Medical Device License (MDL) submissions, whereas the Japanese Pharmaceutical and Medical Devices Agency (PMDA) essentially requires STED formatting for market authorization applications. For the Tech file, requires going through verification and design validation first, whereas you just need to be through verification for the 510(k). As @reshamn notes a big difference is that one needs to submit a clinical evaluation report with the Tech file. Overall two different regulatory requirements, but neither clearly “better” practice than the other. It’ll be interesting to see in the future if this changes and if so, what other countries adopt, or if the US or EU will end up adopting the other’s.

greenlight.guru/blog/technical-file-vs-510-k-vs-design-history-file-dhf
emergogroup/blog/2016/10/what-sted-format-medical-device-technical-documentation