This call aims to support activities contributing to the innovative, sustainable, and competitive EU health industry by enhancing the digitalisation of conformity assessment procedures for medical devices and in vitro diagnostic medical devices under the MDR and IVDR frameworks. The proposed actions will address the challenges manufacturers face, particularly SMEs, by streamlining processes, reducing costs, and increasing efficiency and predictability. Proposals must address feasibility studies, pilots, and roadmaps for digitalisation while involving key stakeholders such as manufacturers, Notified Bodies, and regulatory agencies. Outcomes will support device developers and regulators, contributing to patient safety and public health while maintaining the EU as a business-friendly environment for manufacturers.

Opening: 22-05-2025
Deadline(s): 18-09-2025

Data provided by Kooperationsstelle Wissenschaft

This funding opportunity represents a pre-agreed draft that has not yet been officially approved by the European Commission. The final, approved version is expected to be published in the first quarter of 2025. This draft is provided for informational purposes and may be used to preliminarily form consortia and develop project ideas, but it is offered without any guarantees or warranties.