Eucomed’s Andy Vaughan and Dario Pirovano were invited to speak at the MovingLife Consultation Workshop held at the European Commission on 18 January 2012. The workshop was attended by around 30 people involved in the MovingLife project.
MovingLife (MObile eHealth for the VINdication of Global LIFEstyle) is a support action funded by the European Commission under the 7th Framework Programme, and aims to deliver roadmaps for technological research, implementation practice and policy support. The objective is to accelerate the establishment, acceptance and wide use of mobile eHealth solutions (mHealth) that will support lifestyle changes among citizens and improve disease management globally.
Much of the technology involved will fall within the definition of a ‘medical device’. Eucomed was therefore invited to give the group an overview of how medical devices are regulated and how the various elements associated with device regulation interrelate.
Dario Pirovano described the regulatory situation and highlighted how mobile devices and especially smart phone ‘apps’ may be impacted by the medical device regulations, while Andy Vaughan described how standards could be used to demonstrate compliance with the legal responsibilities.
The questions that the presentations elicited were numerous and probing, indicating a great interest in understanding what medical device regulations may demand from this relatively new but increasingly important method of delivering healthcare.
Questions reflected the group’s concerns about the use of smartphone apps in providing data to doctors, the speed of development of standards and minimum device performance.
Eucomed appreciated the opportunity to contribute to this important area and looks forward to being able to contribute in the future.
