This page grants access to the full compilation of public deliverables generated throughout the project by the CORE-MD consortium.
These documents are the main outputs delivered to the European Commission during the project’s execution and provide a thorough description of the research, policy, advocacy and stakeholder engagement activities performed as well as the results accomplished by the CORE-MD partners. In addition, further details and complementary findings are openly accessible on the page “Results” (CORE-MD results) where all published works are available for download.
Work Package 1
Understanding methods used to generate evidence for high-risk medical devices
D1.1 Database of studies of high-risk medical devices
Task 1.1 is dedicated to map the existing evidence and the methodologies used in published clinical studies of high-risk medical devices through broad systematic reviews of the medical literature. D1.1 contains the protocols of the methodology used for the literature search in the three fields of cardiac, diabetes and orthopedic devices.
D1.2 Repository of trial designs for orthopaedic, cardiovascular and diabetic devices
D1.2 compiles the relevant datasets for the conduction of the three systematic reviews thus providing an open access repository of the study designs and methodologies for clinical investigation of high-risk medical devices with approval for use in Europe. In line with the FAIR principles, the datasets have been made available through Zenodo (see links provided on page 3 of this deliverables)
D1.3 Peer-reviewed manuscripts
The results of the three systematic reviews are concisely presented in D1.3 and discussed in detail in the respective scientific papers.
D1.4 Scientific report on statistical methods for medical device trials
D1.4 describes an algorithm and provides access to an open online tool that can be used by manufacturers, notified body assessors and regulators to evaluate the implications for risk from studies of devices that may have limited sample sizes and/or statistical power.
D1.5 Recommendations on PROMs for conformity assessment and post-market surveillance
D1.5 focuses on PROMs, specifically their use and utility in trials, studies, and post-market surveillance of high-risk medical devices. This research employed two approaches for data gathering, firstly a systematic literature review, and secondly a Delphi study, online surveys and focus groups with patients and caregivers.
D1.6 Report on study design recommendations in guidance documents for high-risk medical devices
In D1.6 we identify guidance documents concerning clinical investigations of high-risk medical devices, describe their contents and compare their principal recommendations for designing, analyzing, and reporting clinical studies, with a focus on methodologies for confirmatory pivotal trials.
Work Package 2
Strengthening clinical evidence for high-risk medical devices: New methods for generating clinical evidence
D2.1 Publication on early-phase clinical studies of high-risk medical devices
WP2 focuses on assessing the potential of new evaluation methodologies which might make clinical evaluation more effective, faster or cheaper. Of particular interest in this regard was the application to medical devices of the IDEAL Framework which is analyzed in D2.1 highlighting potential benefits, enablers and barriers.
D2.2 A publication on the essential principles of randomised registry trials
D2.2 summarizes the essential principles and utility of large simple RCTs, relevant to all interventions but especially in order to promote their wider adoption to evaluate new medical devices.
D2.3 Proposals for a hierarchy of clinical study designs
D2.3 is articulated as an overview of the current landscape of clinical investigations that may be employed for the evaluation of the performance and safety of high-risk medical devices.
D2.4 Expert advice on criteria for the regulatory evaluation of ML and AI
D2.4 proposes recommendations and a risk-scoring system as a basis for developing regulatory guidance on the clinical evaluation of artificial intelligence (AI) or machine learning (ML)-enabled medical devices and on standalone software in medical devices (MDSW) – with a focus on high-risk applications before their first regulatory approval.
D2.5 Consensus recommendations on a desirable regulatory policy for paediatric high-risk medical devices
D2.5 concisely presents the results of the scoping review of published reports on the clinical investigation of high-risk medical devices in children and provides recommendations for appropriate methodologies for evaluating and approving high-risk medical devices for use in children.
Work Package 3
Extracting maximal value from medical device registries and real-world evidence
D3.1 Decision framework to assess the performance of high-risk medical devices
D3.1 provides insights into how registry data and other real-world data sources can be leveraged to supplement evidence from randomized controlled trials (RCTs) on the performance and safety of high-risk medical devices, in the post-marketing phase.
D3.3 Report on conditions on certificates by notified bodies
The MDR allows notified bodies (NBs) to issue certificates of conformity (thereby approving devices) with conditions that manufacturers must then fulfil if they wish their device to remain on the market. In D3.3 the current use of such conditions is described via a systematic review and a survey with NBs.
Work Package 4
Networking and community building: Engaging with stakeholders
D4.1 Roadmap for education and training
The roadmap illustrated in D4.1 presents the training needs of stakeholders namely notified bodies, regulators and clinicians, to develop appropriate educational objectives, and to provide respective recommendations.
D4.2 An Ethics Charter for Innovation in Medical Devices
The Charter presented in D4.2 is a draft for further debate and development which presents a preliminary overview of the ethical requirements relevant to development, evaluation, and regulation during the corresponding phase of the MD life cycle.
D4.3 Recommendations for a hierarchy of clinical evidence for high-risk medical devices
D4.3 compiles CORE-MD recommendations for how EU regulatory systems can implement new methodologies for clinical investigations of high-risk medical devices, using evidence generated across their whole life cycle. These are based on the work undertaken by other WPs and were presented to the regulators.
D4.5 Educational resources
D4.5 illustrates the contents and scope of the 13 CORE-MD webinars 13 organized between January 2023 and March 2024, all of which were made available on a dedicated page of the CORE-MD website as well as on the CORE-MD Youtube channel. Moreover, a series of podcast episodes and the other videos contributed to enrich the offer of CORE-MD’s educational resources.
D4.8 Final report on dissemination and networking
D4.8 presents the CORE-MD’s action on dissemination, communication and networking and documents its widespread impact achieved by creating a cohesive and thriving European regulatory science community that will keep working on common challenges and shared interest beyond the project’s end.
