Source: European Parliament
21.10.2024
Question for written answer E-002192/2024
to the Commission
Rule 144
Beatrice Timgren (ECR), Charlie Weimers (ECR), Dick Erixon (ECR)
The implementation of the Medical Devices Regulation (EU) 2017/745 (MDR) in 2021 has placed an immense bureaucratic burden on manufacturers and clinicians, slowing down processes, increasing costs and stifling innovation in the medical sector[1]. Instead of enhancing patient safety, these regulations have led to delays in the availability of life-saving devices, forcing clinicians to use riskier alternatives[2][3]. This bureaucratic overload not only jeopardises the well-being of countless patients but also threatens the EU’s competitiveness in the global medical industry, with potentially devastating consequences, including the loss of lives.
Given the severity of this situation:
- 1.When will the Commission propose a revision of the MDR to eliminate unnecessary bureaucratic hurdles, especially for small and medium-sized enterprises, and ensure that patient safety and innovation is genuinely prioritised?
- 2.What steps will it take to address bottlenecks in the work of assessment bodies, which have led to dangerous delays and limited access to life-saving devices?
- 3.What lessons has it learned from the implementation of the MDR, and how will it ensure that future policies are developed and implemented in a way that prevents similar regulatory burdens and unintended negative consequences?
Submitted: 21.10.2024