Technical documentation

Technical documentation, sometimes called a technical file, is the set of documents that shows a device meets the applicable general safety and performance requirements.

EU MDR Annexes II and III describe what the file contains: device description, information from the manufacturer, design and manufacturing information, general safety and performance requirements, benefit-risk and risk management, product verification and validation, and the post-market plan. The design history file and the medical device file overlap with it and should not contradict it.

HAVGATE document control can store procedures and specifications. It is not a technical-file authoring system, and it does not generate an MDR Annex II file.