Periodic Reporting for period 1 - CORE-MD (Coordinating Research and Evidence for Medical Devices)
Berichtszeitraum: 2021-04-01 bis 2022-09-30
CORE-MD (Coordinating Research and Evidence for Medical Devices) is a Coordination and Support Action that is led by two major medical professional associations in Europe (the European Society of Cardiology – ESC, and the European Federation of National Associations of Orthopaedics and Traumatology – EFORT). It is unique in bringing together medical experts from universities and clinical societies with colleagues from national regulatory agencies of EU member states, notified bodies, health technology assessment agencies, patients’ organisations, and national institutes of public health, all to consider how best to evaluate high-risk medical devices that are implanted into patients.
A new EU law concerning medical devices was passed in 2017, although it has not yet been fully implemented. It established that high-risk medical devices need to undergo more thorough clinical investigations before they are approved, but it does not recommend which types of investigations are best for which devices. New devices are constantly being developed, some devices are used infrequently for example in children, and for some devices such as artificial intelligence systems there are no clinical standards. The European system for approving devices was not designed to adapt to such challenges but it must be able to provide safe and effective devices for patients.
The main objective of this project is to develop expert recommendations that regulatory authorities can use to set European standards for the clinical investigation of high-risk medical devices.
A new EU law concerning medical devices was passed in 2017, although it has not yet been fully implemented. It established that high-risk medical devices need to undergo more thorough clinical investigations before they are approved, but it does not recommend which types of investigations are best for which devices. New devices are constantly being developed, some devices are used infrequently for example in children, and for some devices such as artificial intelligence systems there are no clinical standards. The European system for approving devices was not designed to adapt to such challenges but it must be able to provide safe and effective devices for patients.
The main objective of this project is to develop expert recommendations that regulatory authorities can use to set European standards for the clinical investigation of high-risk medical devices.
Despite it being essential for healthcare professionals to practise evidence-based medicine, there has been no requirement for transparency of the clinical evidence that has been presented by manufacturers for their devices to be approved in the EU. The first task of the CORE-MD consortium, therefore, has been to review and summarise what study methods have been used and what results are available about devices that are commonly implanted to treat patients with heart disease, arthritis, and diabetes. For example, it has shown that hip implants are usually approved without a clinical trial having been reported.
Such approvals can be balanced by collecting detailed information about devices after they have been implanted. CORE-MD has therefore also reviewed device registries in Europe, which showed that they are not yet designed to provide the results needed by regulators.
The consortium has also investigated specific questions such as how artificial intelligence medical systems can be evaluated. It has reviewed international standards for clinical investigations.
Such approvals can be balanced by collecting detailed information about devices after they have been implanted. CORE-MD has therefore also reviewed device registries in Europe, which showed that they are not yet designed to provide the results needed by regulators.
The consortium has also investigated specific questions such as how artificial intelligence medical systems can be evaluated. It has reviewed international standards for clinical investigations.
The CORE-MD consortium is now analysing the data that it has collected, synthesizing the findings, comparing the evidence against existing standards, and preparing recommendations for particular types of medical devices, and for the optimal designs of clinical trials.
The results will be presented to EU regulators, so that they can be used as the basis for standards and guidance. The hope is that this can lead to safer and more effective devices for patients.
The results will be presented to EU regulators, so that they can be used as the basis for standards and guidance. The hope is that this can lead to safer and more effective devices for patients.