The DHF is a simply the collection of documents from the design to the development process. It is key file that contains all the design controls documentation and therefore it is a requirement by the FDA for the 510k submission. A technical file is very similar version to a DHF except that is a European version for the 510k. The technical file mostly explains that how is a particular product related or conforms to an applicable EU medical device regulations. Although, the technical file follows a format but it is less descriptive. The very big difference between the two documents is the need to submit a clinical evaluation report with the technical file. Both are very important documents and carry weightage in different regions.However the DHF is more detailed and thorough because of its existence from the initial stage.