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Developing EU methodological frameworks for clinical/performance evaluation and post-market clinical/performance follow-up of medical devices and in vitro diagnostic medical devices

Health & Life Sciences
Project Size:

Opening Date: 26 October 2023 Deadline Date: 11 April 2024, 17:00 Brussels time

Expected Outcome: The initiative aims to enhance the regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) by achieving:

· Faster patient access to safe and effective innovative medical devices.

· Regulators' access to scientific resources for guidance on clinical/performance evaluation.

· Harmonised assessment of clinical evidence by notified bodies, enhancing their network.

· Insight for health technology developers on MDR clinical requirements and the use of real-world data in clinical development strategies.


Tackling diseases and reducing disease burden:

Unlocking the full potential of new tools, technologies and digital solutions for a healthy society:

Maintaining an innovative, sustainable and globally competitive health industry:

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.


· 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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