CORE–MD is a European Union Horizon 2020 project, that will run from April 2021 until March 2024. It will review methods for evaluating high-risk medical devices, in order to translate expert evidence into advice for EU regulators and to recommend an appropriate balance between innovation, safety, and clinical effectiveness.
Implementation of the Medical Device Regulation (EU) 2017/745 challenges the medical community to engage with regulators, notified bodies and industry to develop transparent, rigorous and proportionate methods for evaluating the clinical aspects of devices and for monitoring their performance.
The CORE–MD consortium will address this challenge bringing together medical associations, EU regulators, national public health institutes, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, with participation of manufacturers’ trade associations.
Led by the European Society of Cardiology (ESC) in close partnership with the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), the consortium includes 22 partners involved in the development, evaluation, approval and certification, clinical use, and monitoring of medical devices.
WP5 Project management
WP1 Understanding methods used to generate clinical evidence for high-risk medical devices
WP2 Strengthening evidence for high-risk medical devices: New methods for generating clinical evidence.
WP3 Extracting maximal value from medical device registries and real-world evidence.
WP4 Networking and community building
New methods
To advise how new trial designs can strengthen clinical evidence for high-risk devices, WP2 will propose a framework for generating evidence during their early development, consider innovative methodologies like randomised registry trials, propose how to assess artificial intelligence in devices, and review designs for devices in children.
Existing methods
WP1 of CORE-MD will undertake a systematic review of methodologies used in clinical trials to evaluate high-risk medical devices. It will compare guidance for clinical trial designs, review statistical methods for device trials, and assess the utility of patient-reported outcomes for regulatory decisions.
Real-world data
WP3 will investigate how to aggregate and extract maximal value for post-market surveillance from medical device registries, big data, clinical practices and experience, and the internet.
Management
WP5 will manage the CORE-MD project, enabling exchanges between partners and collaborators and ensuring efficient fulfilment of its objectives, supported by a large medical professional society with an excellent track record of EU-funded project coodination and participation.
Networking
WP4 will hold workshops between the CORE-MD consortium and stakeholders to build on outcomes and share insights from WP1-3, proposing a hierarchy of clinical evidence for high-risk devices, an ethics charter for innovation, and a rodmap for educational objectives of stakeholders. Recommendations for the evolution of EU regulatory systems for high-risk devices will be prepared.
Dissemination
Wide consultation using an interactive communication platform together with multimedia dissemination of CORE-MD outputs will be crucial to its success. These will be implemented by WP4.
