Regulatory Update: Between Market Shakeout and Postponement: How the MedTech Industry (should) react to the MDR/IVDR Transitional Periods

Although the extended transition periods of the MDR and IVDR give manufacturers more time to implement the stricter regulatory requirements, they do not completely solve the fundamental problems such as product shortages and market withdrawals. Small and medium-sized companies in particular will continue to be heavily burdened by high certification costs and the considerable conversion effort. The medtech industry should use the additional time to optimize internal processes, critically review the product portfolio and submit applications to notified bodies at an early stage in order to avoid impending delays in the approval process.