Technical documentation
Short definition
Technical documentation is the set of documents the manufacturer must draw up and maintain to demonstrate that the device complies with Regulation (EU) 2017/745.
In plain language
Its content is set out in Annexes II and III of the MDR. It includes the description of the device and its intended purpose, the information supplied to the user, design and manufacturing, safety and performance requirements, risk analysis, clinical evaluation and post-market surveillance. It must be available to the competent authorities and kept up to date throughout the life of the device.