MDR & IVDR Competence Center

The new regulations for medical devices (MDR, implementation deadline by May 26, 2021) and in vitro diagnostics (IVDR, implementation deadline by May 26, 2022) pose major challenges for the affected industries. In order to support small and medium-sized enterprises (SMEs) in Baden-Württemberg in the implementation and further development, the NMI, as the lead organization, will establish an MDR & IVDR Competence Center together with partners. The task of the center will be to accompany SMEs in particular, but also large companies, throughout the life cycle of their product, from development to approval, and thus to support them in meeting the new requirements and testing procedures. The aim is to increase the competitiveness of companies in the field of health technology (medical technology, pharmaceuticals and biotechnology) by pooling scientific, technical and regulatory expertise.

In addition to support and guidance with regard to approval, analytical and test methods that are required but not yet available are developed and, if necessary, standardized in order to enable companies to test their products and thus obtain approval. In addition, already established services are offered and mediated in order to support companies in the interpretation of the results. Furthermore, the qualification of the personnel of the companies concerned is also addressed.

The bundling of competencies in the MDR & IVDR Competence Center enables companies to bring products to market faster and easier. Through strong networking with partners from the Baden-Württemberg Innovation Alliance, Tübingen University Hospital and BIOPRO Baden-Württemberg GmbH, the center serves as a contact point for industrial approvals of safe products.