In light of the recent developments, these changes notably include the inclusion of healthcare institution-produced devices, custom-made devices, single-use devices, devices without a medical purpose, and clinical investigations. Consequently, adapting to these new requirements may indeed require additional resources and the initiation of new processes and systems. Further, the MDR aims to reduce technical barriers to trade and significantly enhance post-market surveillance. As such, as companies begin their preparations for the MDR's implementation, staying ahead of the curve will undeniably be crucial for achieving success in this dynamic and promising market.