Medical device regulation (MDR) in health technology enterprises - perspectives of managers and regulatory professionals.

Abstract in brief

• The study explores how managers and regulatory professionals in Finnish health technology companies perceive and understand the EU Medical Device Regulation (MDR), highlighting the importance of clear information and the role of various information sources, especially Fimea.
• Findings indicate that information about MDR is fragmented and often unsatisfactory, with users mainly relying on multiple sources including Fimea, but expressing some dissatisfaction with its performance and clarity.
• The size of the enterprise influences the number of devices manufactured and perspectives on MDR, with most professionals recognizing the regulation's importance for device safety and transparency, though they feel current information does not fully meet their needs.