DBE and DKF alliance for regulatory framework!
Together, the DBE and the DKF (Department of Clinical Research) want to enable academia to overcome new regulatory obstacles to the development of innovative medical devices.
Switzerland has adapted its legislation to the European Medical Device Regulation (MDR). This new regulation also applies to medical software. The latter are now considered as medical devices of higher risk class, which complicates their development, use and commercialization.
However, MDR rule 11 also emphasizes that software can be used in hospital if the product is only used for that specific healthcare facility and if it can be credibly proven and documented that no equivalent product for the same patient group is available on the market. Based on this section of the regilation, Philippe Cattin (DBE), Oliver Bieri (USB/DBE), and Bram Stieltjes (USB) launched a project in partnership with Ronald John (DKF) to create a sustainable regulatory framework that will allow research groups to use software in hospitals in a standard-compliant manner.
With DKF's support, DBE will apply this regulatory framework to two pilot projects involving the development of machine learning methods for medical image analysis.
More information can be found here