This article proposes possible policy and practice interventions to ensure the continued availability of essential devices for children and people with rare diseases.
In the framework of CORE-MD, Kathrin Guerlich, Bernadeta Patro-Golab, Berthold Koletzko and colleagues provided recommendation on clinical evaluation of paediatric device thereby setting the scene for the article aforementioned.
As the implementation of the Medical Device Regulation is currently being evaluated by the European Commission as part of its mid-term review process, the article written by Tom Melvin, Marc M. Dooms, Berthold Koletzko, Mark A. Turner, Damien Kenny, Alan G. Fraser, Marc Gewillig & Anneliene Hechtelt Jonker stresses the need for a more proactive approach to identifying devices at risk and essential devices, increasing the use of exceptional market approvals and use the potential of expert panels.
