Following the recent plenary session of the European Parliament, the BioMed Alliance publishes a new statement sharing its concerns about the debate on accelerating the evaluation of the Medical Devices Regulation (MDR). The MEPs are calling on the European Commission to release a new proposal within 100 days of being in office. While the Alliance agrees that there are pressing issues that need to be addressed, there are serious concerns that rushing the evaluation process could undermine patient safety and the overall integrity of the MDR.
The MDR was designed to ensure the safety and effectiveness of medical devices through stringent standards. The Alliance agrees that immediate short-term measures are necessary to address pressing issues, including the limited availability of orphan and paediatric devices, however hastily revising the regulation without careful consideration of the impact and consultation with stakeholders risks compromising its robustness. Moreover, these changes may fail to address the deeper structural issues behind the delays, such as problems related to high costs of certification, innovation leaving the market and governance issues.
We urge decision-makers to allow more time for a comprehensive evaluation of the MDR, ensuring that any changes truly benefit patients without sacrificing the regulation's core goals. BioMed Alliance therefore calls on policy makers:
- To support the detailed review of the regulations that the European Commission is currently undertaking
- To avoid implementing short-term legislative measures without a careful diagnosis of the key shortcomings in the system
- To address fundamental problems based on scientific principles
- To ensure that revisions to the IVDR are considered separately, due to the different needs of the diagnostic sector
- To implement targeted short-term measures to mitigate shortages of medical devices, and particularly of orphan devices and paediatric devices, separately from the more comprehensive review of the regulations
The statement is now available here