Update of an existing product at a pharmaceutical company for approval according to IVDR

The previously developed product was to undergo some improvements in this iteration that would increase user-friendliness and obtain IVDR approval. The primary changes therefore relate to the technical documentation for IVDR approval. In the course of this, certain incorrect assumptions regarding the development approach were corrected in order to map a reliable development. The difficulty with this product lies in the connection/dependence on the development of biomarkers, which is ultimately where the greatest project risks are located. The data from biomarker development is crucial for the development, verification and validation of the algorithm. This dependency also poses a difficulty in how such projects can be designed, implemented and realized.