Periodic Reporting for period 1 - CORE-MD (Coordinating Research and Evidence for Medical Devices)
Reporting period: 2021-04-01 to 2022-09-30
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.
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 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.