Developing EU methodological frameworks for clinical/performance evaluation and post-market clinical/performance follow-up of medical devices and in vitro diagnostic medical devices (IVDs)
- Research is needed to help regulators develop common methodological frameworks (including common specifications) on the clinical evidence needed to demonstrate safety, performance and clinical benefit all along the life cycle of devices taking into account the type of device and clinical intended purpose.
- Such methodological frameworks and standardized approaches are particularly needed for high-risk medical devices, e.g. implantable and class III medical devices, class C and D IVDs, medical device software (including AI enabled devices and next generation sequencing) and other highly innovative devices.
- For medical devices, a pilot to support development of common specifications which would set the stage for a common specification ecosystem for medical devices in the EU, including the development of standardized/common endpoints and associated health outcomes measures by technology type and where relevant by clinical intended purpose;
- Development of a general methodological approach to define, determine and update the state of the art for different device technologies. The robustness of the developed approach should be evaluated on 3 different medical device types and 3 different IVD types
Total budget: 10 M€
Per project: 8-10 M €
Open: 26 October 2023
Deadline: 11 April 2024
More information: Pre-publication work programs Horizon Europe: Horizon Europe work programmes (europa.eu) see cluster 1 work program.