Scope: The call addresses the need for a structured methodological framework for clinical and performance evaluation of medical devices and IVDs, emphasizing high-risk devices. It reflects the Medical Device Regulation (MDR) and in vitro diagnostic medical device Regulation (IVDR) requirements for clinical data assessment throughout a device's life cycle.

Key Activities:

· Development of a life-cycle evidence generation and evaluation framework for high-risk and innovative medical devices and IVDs.

· A pilot project for developing common specifications for medical devices, including standardized endpoints and health outcomes measures.

· Methodological approach to define and update the state of the art for device technologies, tested on various medical device and IVD types.

· Utilization of registries and real-world data for pre- and post-market regulatory compliance, including methodology for bridging studies.

· Integration of evidence from various data sources in clinical/performance evaluation.

Objectives:

· To standardize the approach for clinical and performance evaluation of medical devices and IVDs across the EU.

· To support the development of common specifications as per Article 9 of the MDR.

· To improve the collaboration among stakeholders including regulators, notified bodies, healthcare providers, and technology developers.

Involvement: Proposals should engage with national competent authorities, notified bodies, IVD laboratories,

Health Technology Assessment bodies, and potentially patients' representatives, building on existing EU-funded initiatives and involving experts in medical device/IVD evaluation and real-world data analysis.

This funding opportunity seeks to solidify the EU's position in ensuring the innovative, sustainable, and competitive development of medical devices and IVDs, catering to unmet medical needs and enhancing patient care through advanced regulatory frameworks.

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