Coordinating Research and Evidence for Medical Devices

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

A publication on the essential principles of randomised registry trials

Scientific report on the lessons learned from running randomised registry trials in Sweden, and the infrastructure and supporting technology that are required, so that they can be adapted for other contexts and applied to provide results appropriate for regulatory submissions.

Recommendations for a hierarchy of clinical evidence for high-risk medical devices

The CORE–MD consortium will present its conclusions in summary recommendations concerning a hierarchy of types of methodologies to generate clinical evidence, as well as needs for future research and developments in EU regulatory science.

Database of studies of high-risk medical devices

Central database of published studies that have generated evidence on high-risk medical devices with approval for use in Europe, ordered according to the hierarchy of levels of evidence developed in WP3.

Expert advice on criteria for the regulatory evaluation of ML and AI

Expert advice on how machine learning and artificial intelligence high-risk implementations should be evaluated before use and after implementation from a clinical patient value perspective.

Proposals for a hierarchy of clinical study designs

A consensus statement for regulators concerning the scientific validity of clinical study designs for medical devices, from pilot observational studies to large randomised controlled trials and including new methodologies, ranked according to their reliability and utility.

Final report on dissemination and networking

A detailed report describing all the WP activities implemented from Month 19 to Month 36, such as organising meetings, conferences and webinars, participation in external events and congresses, publishing articles, conducting surveys and public consultations, etc.

Decision framework to assess the performance of high-risk medical devices

• Review of endpoints and methods used to assess performance of medical devices in EU registries, and potentially relevant endpoints from other data sources• Proposed framework to assess performance of medical devices, endpoints included and the methods used to combine outcomes into a single benchmark. This will include recommendations on the criteria for reliable estimation, grouping of medical devices and proposed timepoints for benchmarking.

Report on conditions on certificates by notified bodies

A publication with the results of EU and other experience relating to clinical evidence generation after market access.

An Ethics Charter for Innovation in Medical Devices

Following preparatory work by ESC and EFORT, informed by conclusions from Tasks 2.1 and 2.4 and discussions at a workshop, an Ethics Charter will be recommended to guide practice by innovators, developers, and clinicians involved in the design, feasibility and early studies, and clinical trials of new high-risk medical devices.

Scientific report on statistical methods for medical device trials

Expert recommendations on methods for evaluating clinical trials and studies of highrisk medical devices

Dissemination & Communication Plan

Definition of COREMD dissemination and communication activities providing detailed information on brand recognition target groups media synergies

Report on dissemination and networking

A detailed report describing all the WP activities implemented at Month 18 such as organising meetings conferences and webinars participation in external events and congresses publishing articles conducting surveys and public consultations etc

Recommendations on PROMs for conformity assessment and post-market surveillance

Including a literature review on disease-specific PROMS currently used, with a focus on minimally important clinical differences, sample size and follow-up intervals to enable discrimination in performance of devices, and a Core Outcome Set from the perspective of patients.

Report on study design recommendations in guidance documents for high-risk medical devices

Published manuscript summarising both consensus recommendations from academic consortia and professional associations, and regulatory guidance documents from international jurisdictions, concerning methodologies for clinical trials of high-risk medical devices, that were identified during the CORE-MD systematic review.

Roadmap for education and training

A survey on needs for clinical and methodological expertise and on needs for additional regulatory guidance perceived by NB is conducted under the auspice of Team-NB. The survey results are clustered according to overlapping topics (M12: Team NB, TÜV Süd). Based on structured dialogues among stakeholders (see D 4.3) a plan is developed for advanced training of staff NB members, scientific/clinical experts (incl. elements such as development of internship scheme, short-term sabbatical attachments with manufacturers, notified bodies, competent authorities) and a roadmap (M36, Team NB, Biomed Alliance).

Consensus recommendations on a desirable regulatory policy for paediatric high-risk medical devices

A report on criteria for accepting evidence for regulatory purposes from clinical studies of high-risk devices in children, when sample sizes may be small, with a discussion of methods for generating and evaluating evidence for orphan medical devices including the balance between pre- and post-market data, the need for compassionate use approvals, and priorities for methodological research.

Project handbook

This document presents the Project coordination aspects and the Project supporting procedures More specifically it describes the knowledge base which consists of procedures tools and information needed to manage and support the Projects activities Finally it contains three sections devoted to Quality Plan to the Risk Management Plan and to Ethical Issues

Peer-reviewed manuscripts

Publication of main analysis and principal secondary/sensitivity analyses.

Publication on early-phase clinical studies of high-risk medical devices

Report on the utility of the IDEAL recommendations for innovative medical device studies and their relevance to the framework of the MDR.

Project Website

Create and maintain a project website coremdeu that will be regularly updated A mission statement will be highlighted in the homepage The web site will offer general information in English about the project its partners and H2020 Programme It will inform about events and activities of the project as well as other relevant news on project topics It will be used for dissemination towards stakeholders and the public Through it open consultations on draft recommendation from the consortium will also be conducted A search box will be an integral part of the site search functionality of the project website Google Analytics will be used to monitor the traffic of the website

Repository of trial designs for orthopaedic, cardiovascular and diabetic devices

Central cross-specialty repository of the design and methodology of clinical investigations for high-risk medical devices with approval for use in Europe.

Educational resources

Each Task in CORE-MD will create a 1-hour webinar that will be available for viewing on the project website, to summarise its findings, conclusions, and questions.

Pubblicazioni

Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management: A statement of the ESC Association of Cardiovascular Nursing and Allied Professions (ACNAP), the Association for Acute CardioVascular Care (ACVC), European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Association of Preventive Cardiolog

Autori: Moons, P., Norekvål, T. M., Arbelo, E., Borregaard, B., Casadei, B., Cosyns, B., Cowie, M. R., Fitzsimons, D., Fraser, A. G., Jaarsma, T., Kirchhof, P., Mauri, J., Mindham, R., Sanders, J., Schiele, F., Torbica, A., & Zwisler, A. D.
Pubblicato in: European Heart Journal, Numero Volume 44, Numero 36, 2023, Pagina/e 3405-3422
Editore: Oxford Academy
DOI: 10.1093/eurheartj/ehad514

Randomized controlled trials remain underutilized

Autori: Siontis, G. C. M., Frenk, A., & Windecker, S.
Pubblicato in: European Health Journal, Numero Volume 45, Numero 7, 2024, Pagina/e 553-554
Editore: Oxford University Press
DOI: 10.1093/eurheartj/ehad806

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review

Autori: Hoogervorst, L. A., Geurkink, T. H., Lübbeke, A., Buccheri, S., Schoones, J. W., Torre, M., Laricchiuta, P., Piscoi, P., Pedersen, A. B., Gale, C. P., Smith, J. A., Maggioni, A. P., James, S., Fraser, A. G., Nelissen, R. G. H. H., & Marang-van de Mheen, P. J.
Pubblicato in: International Journal of Health Policy and Management, Numero Volume 12, Numero 1, 2023, Pagina/e 1-11
Editore: Kerman University of Medical Sciences
DOI: 10.34172/ijhpm.2023.7648

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

Autori: Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P
Pubblicato in: EFORT Open Reviews, Numero Volume 6, Numero 10, 2021, Pagina/e 839–849
Editore: EFORT
DOI: 10.1302/2058-5241.6.210081

Clinical evidence for high-risk medical devices in cardiology: A protocol for a systematic review and meta-epidemiological investigation.

Autori: Siontis, G. C., Frenk, A., Coles, B., Bartkowiak, J., McGovern, L., Häner, J., Tomii, D., Galea, R., Häberlin, A., Praz, F., & Windecker, S.
Pubblicato in: 2022
Editore: PROSPERO

Clinical evidence for high-risk medical devices used to manage diabetes: protocol for a systematic review and meta-analysis

Autori: Bano, A., Laimer, M., Wehrli, F., Kunzler, J., Rivero, T., Fraser, A. G., Stettler, C., Hovorka, R., & Bally, L.
Pubblicato in: BMJ, Numero Volume 13, Numero 4, 2023
Editore: BMJ
DOI: 10.1136/bmjopen-2022-070672

Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium

Autori: Siontis, G. C. M., Coles, B., Häner, J. D., McGovern, L., Bartkowiak, J., Coughlan, J. J., Spirito, A., Galea, R., Haeberlin, A., Praz, F., Tomii, D., Melvin, T., Frenk, A., Byrne, R. A., Fraser, A. G., Windecker, S., & CORE-MD Investigators
Pubblicato in: European Heart Journal, Numero Volume 43, Numero 3, 2021, Pagina/e 161-177
Editore: Oxford University Press
DOI: 10.1093/eurheartj/ehad567

European cardiovascular registries as reliable data sources to assess implants safety and performances across the implant lifecycle

Autori: Hoogervorst, L. A., Geurkink, T. H., Schoones, J. W., Buccheri, S., James, S., Gale, C. P., Fraser, A. G., Nelissen, R. G. H. H., Marang-Van De Mheen, P. J., & Coordinating Research and Evidence for Medical Devices (CORE-MD) consortium
Pubblicato in: European Heart Journal, Numero Volume 44, Numero Supplement_2, 2023
Editore: Oxford University Press
DOI: 10.1093/eurheartj/ehad655.3001

Evidence from clinical trials on high-risk medical devices in children: a scoping review

Autori: Guerlich, K., Patro-Golab, B., Dworakowski, P., Fraser, A. G., Kammermeier, M., Melvin, T., & Koletzko, B.
Pubblicato in: Pediatric research, Numero Volume 95, Numero 3, 2024, Pagina/e 615-624
Editore: Springer Nature
DOI: 10.1038/s41390-023-02819-4

Orthopedic and cardiovascular medical device registries in Europe: a systematic review

Autori: Hoogervorst, L.
Pubblicato in: 2022
Editore: OSF

Clinical evidence for high-risk medical devices in cardiology: A protocol for a systematic review and meta-epidemiological investigation

Autori: Siontis, G. C., Frenk, A., Coles, B., Bartkowiak, J., McGovern, L., Häner, J., Tomii, D., Galea, R., Häberlin, A., Praz, F., & Windecker, S.
Pubblicato in: National Institute for Health and Care Research, 2022
Editore: PROSPERO

Perceived training needs of regulators, notified bodies and clinicians for a (successful) implementation of the Medical Device Regulation: survey results

Autori: Wild C., Ettinger S.
Pubblicato in: Journal of Medical Device Regulation, Numero Volume 20, Numero 2, 2023, Pagina/e 45-56
Editore: Global Regulatory Press

Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature

Autori: Lübbeke, A.
Pubblicato in: EFORT Open Reviews, Numero Volume 8, Numero 11, 2024, Pagina/e 781-791
Editore: Zenodo
DOI: 10.5281/zenodo.10623389

Dataset - CORE-MD Post-Market Surveillance Tool (Version 1.0.0)

Autori: Ren, Y., & Caiani, E. G.
Pubblicato in: Zenodo, 2024
Editore: Zenodo
DOI: 10.5281/zenodo.10864069

Development of an AI-based IT tool to support medical device nomenclature standardization for post-market surveillance by automated mapping from GMDN to EMDN standards

Autori: Gibello R., Ren Y., Caiani E.G.
Pubblicato in: European Heart Journal, Numero Volume 44, Numero Supplement_2, 2023
Editore: Oxford University Press
DOI: 10.1093/eurheartj/ehad655.3024

Artificial intelligence in medical device software and high-risk medical devices - a review of definitions, expert recommendations and regulatory initiatives

Autori: Fraser, A. G., Biasin, E., Bijnens, B., Bruining, N., Caiani, E. G., Cobbaert, K., Davies, R. H., Gilbert, S. H., Hovestadt, L., Kamenjasevic, E., Kwade, Z., McGauran, G., O'Connor, G., Vasey, B., & Rademakers, F. E.
Pubblicato in: Expert review of medical devices, Numero Volume 20, Numero 6, 2023, Pagina/e 467-491
Editore: Taylor & Francis
DOI: 10.1080/17434440.2023.2184685

Quality and transparency of clinical evidence for high-risk cardiovascular medical devices: a long way to go

Autori: Szymański, P., & Redberg, R.
Pubblicato in: European Heart Journal, Numero Volume 45, Numero 3, 2024, Pagina/e 178-180
Editore: Oxford University Press
DOI: 10.1093/eurheartj/ehad786

MT4 Study Design Recommendations in ISO Standards for High-Risk Medical Devices: A Systematic Review of the HORIZON 2020 Core-MD Project

Autori: Schnell-Inderst, P., Kuehne, F., Holborow, R., Rochau, U., & Siebert, U.
Pubblicato in: Value in Health, Numero Volume 25, Numero 12, 2022
Editore: Elsevier Inc
DOI: 10.1016/j.jval.2022.09.1878

Achieving consensus on items needed to assess the quality and analysis of registry data for the regulatory evaluation of medical device performances during post-market surveillance: which items are the minimum requirements?

Autori: Hoogervorst, L.
Pubblicato in: OSG Registries, 2023
Editore: OSF
DOI: 10.17605/osf.io/r87vt

Clinical evidence for high-risk medical devices in children: A protocol for a scoping review

Autori: Guerlich, K., Bernadeta, P., Michael, K., Paulina, D., & Berthold, K.
Pubblicato in: OSF REGISTRIES, 2023
Editore: OSF
DOI: 10.17605/osf.io/uzekt

Clinical investigations to evaluate high-risk orthopaedic devices: systematic review and meta-analysis

Autori: Smith, J. A., Combescure C., Barea C., Lübbeke-Wolff A.
Pubblicato in: 2021
Editore: OSF
DOI: 10.17605/osf.io/9bjqv

Clinical evidence for high-risk CE-marked medical devices for glucose management: a systematic review and meta-analysis (Version 1)

Autori: Bano, A.
Pubblicato in: Zenodo, 2025
Editore: Zenodo
DOI: 10.5281/zenodo.10894441

Clinical investigations to evaluate high-risk cardiovascular devices: a systematic review of the peer-reviewed medical literature

Autori: Siontis, G.
Pubblicato in: Zenodo, 2024
Editore: Zenodo
DOI: 10.5281/zenodo.10617117

An Integrative Systematic Review of Patient Reported Outcome Measures (PROMs) Used to Evaluate Orthopedic, Cardiovascular, and Diabetes High-Risk Implantable Medical Devices

Autori: Chaplin, J., Rolfson, O., Jarke, H., Moons, P., Norekvål, T., & Holm Ingelsrud, L.
Pubblicato in: National Institute for Health and Care Research, 2022
Editore: PROSPERO

Orphan Medical Devices and Pediatric Cardiology - What Interventionists in Europe Need to Know, and What Needs to be Done

Autori: Melvin T., Kenny D., Gewillig M., Fraser A.G.
Pubblicato in: Pediatric Cardiology, Numero Volume 44, Numero 2, 2023, Pagina/e 271-279
Editore: Springer Nature
DOI: 10.1007/s00246-022-03029-1

Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices' Post-Market Surveillance

Autori: Ren, Y., Bertoldi, M., Fraser, A. G., & Caiani, E. G.
Pubblicato in: Therapeutic Innovation & Regulatory Science, Numero Volume 57, Numero 3, 2023, Pagina/e 589-602
Editore: Springer Nature
DOI: 10.1007/s43441-022-00493-y

Post-approval evidence development schemes established by regulatory authorities for high-risk medical devices: A protocol for a systematic review

Autori: López, J. A., Dobrzynska, A., Lozano, M. P. R., Parrilla, J. C. R., Epstein, D. M., & Amaro, J. A. B.
Pubblicato in: National Institute for Health and Care Research, 2023
Editore: PROSPERO

Study design recommendations in guidance documents for high-risk medical devices. A systematic review.d

Autori: Schnell-Inderst, P., Kühne, F., Rochau, U., Schmid, D., & Siebert, U.
Pubblicato in: 2022
Editore: OSF

Development of a mapping tool between EMDN and GMDN nomenclatures to support post-market surveillance of medical devices

Autori: Gibello, R.
Pubblicato in: 2023
Editore: POLIMNI

Use of patient-reported outcome measures in clinical trials of closed-loop insulin systems – a systematic review

Autori: Ivan Gibanica I.
Pubblicato in: 2023
Editore: GOETEBORGS UNIVERSITET

A Review of MCID in relation to Patient-Reported Outcome Measures used to evaluate orthopedic, high-risk implantable medical devices and surgeries

Autori: Chaplin J.
Pubblicato in: Quality of Life Research, Numero Volume 32, Supplement_2, 2023, Pagina/e 23-220
Editore: Springer Nature
DOI: 10.1007/s11136-023-03530-x

Development of an IT tool to support post-market surveillance and expert panels in detecting sentinel signals relevant to serious incidents in high-risk medical devices: pilot on Italian data

Autori: Ren Y., Bertoldi M., Caiani E.G.
Pubblicato in: European Heart Journal, Numero Volume 43, Numero Supplement_2, 2022
Editore: Oxford University Press
DOI: 10.1093/eurheartj/ehac544.2842

Development of a Framework Dealing with Partial Data Unavailability and Unstructuredness to Support Post-Market Surveillance

Autori: Ren Y. and Caiani E.G.
Pubblicato in: 2023 IEEE EMBS International Conference on Biomedical and Health Informatics (BHI), 2023, Pagina/e 1-4
Editore: IEEE
DOI: 10.1109/bhi58575.2023.10313402

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).

Autori: A G Fraser; R G H H Nelissen; P Kjærsgaard-Andersen; P Szymański; T Melvin; P Piscoi; Alan Fraser; Piotr Szymański; Chris P Gale; Aldo P. Maggioni; Elisabetta Zanon; Christina Dimopoulou; Cinzia Ceccarelli; Polyxeni Vairami; Anett Ruszanov; Per Kjærsgaard-Andersen; Rob Nelissen; Adrian Ott; Elizabeth Macintyre; Loredana Simulescu; Marieke Meijer; Berthold Koletzko; Sarah Wieczorek; Adamos Hadj
Pubblicato in: European Heart Journal - Quality of Care and Clinical Outcomes, Numero Volume 8 , Numero 3, 2021, Pagina/e 249–258, ISSN 2058-1742
Editore: Oxford University Press on behalf of the European Society of Cardiology
DOI: 10.1093/ehjqcco/qcab059

Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature

Autori: Lübbeke, A., Combescure, C., Barea, C., Gonzalez, A. I., Tucker, K., Kjærsgaard-Andersen, P., Melvin, T., Fraser, A. G., Nelissen, R., & Smith, J. A.
Pubblicato in: EFORT Open Reviews, Numero Volume 8, Numero 11, 2023, Pagina/e 781-791, ISSN 2058-5241
Editore: British Editorial Society of Bone & Joint Surgery
DOI: 10.1530/eor-23-0024

European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children

Autori: Guerlich, K., Patro-Golab, B., Barnacle, A., Baumann, U., Eicken, A., Fraser, A. G., Gruszfeld, D., Haas, N. A., Jonker, A. H., Kammermeier, M., Kenny, D., Kolaček, S., Lapatto, R., Maconochie, I., Mader, S., McGauran, G., Melvin, T., Muensterer, O., Piscoi, P., Romano, A.
Pubblicato in: European Academy of Paediatrics, Numero Volume 112, Numero 11, 2023, Pagina/e 2440-2448, ISSN 0803-5253
Editore: Taylor & Francis
DOI: 10.1111/apa.16919

Clinical evidence for high‐risk <scp>CE</scp>‐marked medical devices for glucose management: A systematic review and meta‐analysis

Autori: Arjola Bano, Juri Künzler, Faina Wehrli, Lum Kastrati, Tania Rivero, Adea Llane, Angelica Valz Gris, Alan G. Fraser, Christoph Stettler, Roman Hovorka, Markus Laimer, Lia Bally, null null
Pubblicato in: Diabetes, Obesity and Metabolism, 2024, ISSN 1462-8902
Editore: Blackwell Publishing Inc.
DOI: 10.1111/dom.15849

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