A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system.
EU enforcement authorities may demand a copy of the technical file for many years after the last product was made.
It can include drawings, specifications, reports, review records, meeting minutes, labels, instructions for use, software source code, production process flow charts, etc.
One document may be named "technical file" and list all other documents that are considered part of the technical file but it can be made available to the competent authority on request.
Annex II and III of the EU medical device regulation (MDR) and of the In-vitro Diagnostic Regulation (IVDR) contain an overview of the contents and structure of a technical file, here called Technical documentation.