According to the new European regulation, Medical Device Regulation (MDR), continuous learning is not allowed in medical devices. At least this is how MDR is currently interpreted by leading experts. In the USA, a different approach is being taken, and it should be allowed under strict conditions. In any case, new concepts for product development in medical technology must be developed in favour of the use of artificial intelligence.
This project presents concepts how artificial intelligence (AI/KI) can be optimally used in the highly regulated environment of medical devices.