Orphan and Breakthrough Devices: A New Route Through the MDR / IVDR Reform

Join Irina Rebin and regulatory expert Bartosz Świdrak for an insightful Coffee Break Life Sciences session exploring one of the most significant developments in the proposed MDR and IVDR reform.

The European Commission is introducing a dedicated pathway for orphan and breakthrough devices, designed to support innovative technologies and products addressing small patient populations. Learn what the proposed designation criteria are, how priority and rolling reviews could work in practice, and what opportunities early scientific advice may create for manufacturers.

Whether you are developing novel medical technologies or planning your future regulatory strategy, this session will help you understand what the changes could mean for your business—and what steps you can already take while the proposal moves through Parliament and Council.

Register now and stay ahead of the evolving European regulatory landscape.