CORE-MD

 

Project information

• Full title: Coordinating Research & Evidence for Medical Devices (CORE-MD)
• Duration: 1 April 2021 to 31 March 2024; 35.5 months
• Status: Ongoing
• Funding programme: Horizon 2020 – the European Union Framework Programme for Research and Innovation (Grant agreement ID: 965246)

What will the project do? 

• CORE-MD is the first formalised group of stakeholders in Europe working together to identify ways to enable the scientific, fair, and systematic evaluation of high-risk medical devices.
• The CORE-MD project comes at a timely moment, following the Adoption of the new EU Medical Devices and In Vitro Medical Devices Regulations, which will enter into effect on 26 May 2021(Medical Devices), and 26 May 2022 (In Vitro Medical Devices).

What are the expected outcomes?

• The project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness.
• The project will:
  • systematically review methodologies for the clinical investigation of high-risk medical devices;
  • recommend how new trial designs can contribute;
  • advise on methods for aggregating real-world data from medical device registries.

What is EPFs’ role?

• EPF will support the consortium in identifying the best suited patient-reported outcome measures (PROMs) to discriminate between well-performing and under-performing high-risk medical devices and how to adapt them.
• These measures will ensure that patient engagement is part of this task from the very beginning of establishing PROMs.

Why does this matter for patients?

• Patient Reported Outcomes refers to information reported directly by a patient about their own health condition- they are based only on a patient’s perception of their condition and its treatment.
• Determining the right PROMs for the CORE-MD project can help to include patient’s experiences and reports on measurements that truly matter to them, and that these measurements take into account the role and function of the medical device on a patients’ condition, and are not only based on general indicators.
• As an example, the right PROM can help us ensure that a measurement for an orthopaedic device includes ‘increased well-being’ as an indicator; on the other hand, it can help us ensure that a measurement for a cardiovascular emergency device includes the patients’ survival as an indicator. Each type of device should have the right PROM.

The consortium:

• The project is a unique collaboration between 22 partners: medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies.
  • European Society of Cardiology
  • European Federation of the National Associations of Orthopaedics and Traumatology(EFORT)
  • Biomedical Alliance
  • European Academy of Paediatrics
  • European Patients Forum
  • Academisch Ziekenhuis Leiden(Leiden University Medical Center)
  • The Chancellor, Masters and Scholars of the University of Oxford
  • Region Uppsala
  • Royal College of Surgeons in Ireland 
  • Insel Gruppe Ag(University Hospital Bern) 
  • Katholieke Universiteit Leuven
  • UMIT - Private Universität für Gesundheitswissenschaften, Medizinischeinformatik und Technik GmbH(University for Health Sciences, Medical Informatics and Technology, Hall in Tirol, Austria)
  • Göteborgs Universitet(Gothenburg University) 
  • Politecnico di Milano(Polytechnic University of Milan)
  • Health Products Regulatory Authority(Dublin) 
  • Laegemiddelstyrelsen(Danish Medicines Agency, Copenhagen)
  • Urzad Rejestracji Produktow Leczniczych, Wyrobow Medzycznych i Produktow Biobojczych(Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Warsaw)
  • Rijksinstituut Voor Volksgezondheid en Milieu (National Institute for Public Health and the Environment, Bilthoven, the Netherlands) 
  • Istituto Superiore di Sanita(Italian National Institute of Health, Rome) 
  • HTA Austria - Austrian Institute for Health Technology Assessment GmbH(Vienna)
  • Fundacion Publica Andaluza Progreso y Salud(Progress and Health Foundation, Sevilla) 
  • European Association of Notified Bodies for Medical Devices