Manufacturers of medical devices seeking to place their products on the EU Single Market need to have the conformity of their products assessed according to the applicable conformity assessment procedures outlined in the MDR Annexes IX to XI (1) (2)].
Depending on the procedure selected, manufacturers may also have to involve a notified body. In any case, Technical Documentation for the medical devices needs to be drawn up and kept up to date by the manufacturers.
This document aims to familiarize stakeholders with the requirements outlined in Annex II to the Medical Device Regulation. It provides information on the elements that need to be included in the Technical Documentation and how it can be provided to TÜV SÜD.
Download the Technical Documentation