 The European Union's Medical Device Regulation, MDR, has been implemented since 2017 and is intended to provide a more transparent, robust, predictable, and sustainable regulatory framework for medical device manufacturers. However, this study found that the managers and regulatory professionals in health technology enterprises have limited knowledge of the MDR and its requirements. They also reported having difficulty accessing the necessary information from multiple sources, including the Finnish Medicines Agency, FIMIA. Additionally, the managers and regulatory professionals expressed dissatisfaction with the performance of FIMIA. Furthermore, the size of an enterprise appeared to affect how many medical devices it manufactured and how it viewed the MDR. Overall, the study suggests that further efforts should be made to ensure that the MDR is effectively applied and that the information needs of enterprises are met. This article was authored by Juha Matihusko, Ola Marie Kinyunen, and Paiju Soranto.