The European Arthroplasty Register Network EARN is a non-profit scientific society of registries as well as individual experts in the field of outcome research based on registries who have committed to supporting regulatory efforts to utilize real-world datasets to demonstrate and improve the safety and performance of medical devices.
Although quality registries have been established in many countries and for various devices for decades and there is plenty of evidence for their efficacy, regulatory bodies recognized them as a valuable data source only a few years ago.
In the EU they were first mentioned as a requirement by Guidance MEDDEV 2.7/1 rev 4 applicable since 2016 and their use is enforced by requirements of the Medical Device Regulation. Outside of Europe their use is also required, for example by the FDA, although not on the same legal level as in Europe.
The use of registry data makes it possible to meet higher requirements on clinical data and evidence for market approval and market monitoring by reasonable investments. Details for data handling and evaluations, particularly when used in regulatory processes, have to be developed and established. This shall be performed preferably in cooperation between experts of all fields involved. EARN provides a platform for these activities as well as for research projects.