Almost half of medtech companies expect to spend 5% or more of their annual revenue on the EU Medical Device Regulation, results of a 101-company survey conducted by German software company Climedo Health suggest.
The firm's analysis of survey data reported that hiring extra staff, investing in clinical development and the initiation of other activities needed to comply with the delayed-but-still-looming European Union regulation are driving up costs at medtech companies.
The costs are, in part, a reflection of ongoing uncertainty about the impact of MDR. Almost 70% of the surveyed companies spend most of their MDR-focused time trying to understand the new requirements.