Bionic vision restoration systems incorporating an implantable device belong to the highest regulatory risk class in the USA and Europe (i.e Class III). As such, their release to the market or their use in clinical trials is subject to authorization by the competent authorities. These authorizations are based on thorough evaluation procedures which impose on the manufacturer the highest level of evidence of compliance with regulatory requirements. In order to obtain these authorizations in the shortest possible time, it is necessary to understand, in detail, the requirements specified in the regulations and their interpretation by the competent authorities. The means of demonstration of conformity and the criteria for acceptance must also be defined to ensure that they meet the expectations of the competent authorities. In the case of breakthrough innovation, these different aspects are even more difficult to determine as there is no predicate or state of the art on which the manufacturer and the competent authorities can rely. It is therefore necessary to deploy a regulatory strategy very early on incorporating as much input as possible from the competent authorities, in order to increase the probability of approval and thus streamline the regulatory pathway. We will present, as an example, the method we developed for the Prima Bionic Vision System and discuss the specificities of medical devices; including incremental development and short development cycles versus regulatory time and how to manage this particularity for breakthrough devices.