Avicenna Alliance MDR Revision Proposals to the European Commission
Avicenna Alliance recommendations align with the European Parliament’s recent resolution, calling for urgent action to address regulatory bottlenecks, improve efficiency, and support innovation in the European medical device sector. A key focus of our proposals is the acceptance of digital evidence from in silico methods for pre-clinical AND clinical investigation, including in silico clinical trials (ISCT), to accelerate market access while ensuring patient safety.
The Alliance will continue to work closely with EU policymakers and stakeholders to ensure that the regulatory framework remains predictable, efficient, and innovation-friendly.
