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EU MDR costing smaller medtechs 5% of their annual sales: survey

  • 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.

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