Deliverables
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 AIExpert 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 designsA 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.
Report on conditions on certificates by notified bodiesA publication with the results of EU and other experience relating to clinical evidence generation after market access.
An Ethics Charter for Innovation in Medical DevicesFollowing 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 trialsExpert recommendations on methods for evaluating clinical trials and studies of highrisk medical devices
Dissemination & Communication PlanDefinition of COREMD dissemination and communication activities providing detailed information on brand recognition target groups media synergies
Report on dissemination and networkingA 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 surveillanceIncluding 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 devicesPublished 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 trainingA 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).
Project handbookThis 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 manuscriptsPublication of main analysis and principal secondary/sensitivity analyses.
Publication on early-phase clinical studies of high-risk medical devicesReport on the utility of the IDEAL recommendations for innovative medical device studies and their relevance to the framework of the MDR.
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
Central cross-specialty repository of the design and methodology of clinical investigations for high-risk medical devices with approval for use in Europe.
Educational resourcesEach 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.
Publications
Author(s):
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P
Published in:
EFORT Open Reviews, Issue Volume/Issue: Volume 6: Issue 10, 2021, Page(s) 839–849
Publisher:
EFORT
DOI:
10.1302/2058-5241.6.210081
Author(s):
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
Published in:
European Heart Journal - Quality of Care and Clinical Outcomes, Issue Vol. 8 , no. 3 , pp. 249–258, 2021, ISSN 2058-1742
Publisher:
Oxford University Press on behalf of the European Society of Cardiology
DOI:
10.1093/ehjqcco/qcab059
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