Technical documentation

1. 1All above facts need to be consolidated in a searchable, organised and conclusive technical documentation (MDR Annex II). The MDR requires that not only data need to be presented but detailed information on the tests, test protocols and methods of analysis and test conclusions.
2. 2The technical documentation provides a summary of the development path, the transfer in production as well as design and process control and change management processes. The manufacturer needs to demonstrate to be in full control.
3. 3With the MDR the technical documentation does not end with the marketed CE-marked device but continues over the expected lifetime. The MDR Annex III structures the content of the technical documentation on Post-Market Surveillance considering also proactively gathered information to help continuously assessing the risk-benefit of the marketed device on basis of literature, user feedbacks and other sources of clinical data.