The Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) pose major challenges for the companies and sectors concerned. In order to support the implementation and further development, the MDR & IVDR Competence Centre is being established. Here, consulting and development capacities are available to the industry in order to support – especially new, innovative products – in meeting with the regulatory requirements. The partners are NMI Natural and Medical Sciences Institute in Reutlingen, Hahn-Schickard-Gesellschaft für angewandte Forschung e.V. and BIOPRO Baden-Württemberg. The aim will be to increase the competitiveness of companies in the healthcare industry by pooling scientific, technical and regulatory competencies, which is made possible by close cooperation between partners. BIOPRO provides support in coordination and management set-up as well as in communication.
The MIK project is funded by the Ministry of Economics, Labor and Tourism as part of the Forum Health Region BW.