Members of the CORE-MD consortium met recently for the first time in person. More than 50 investigators gathered at the University of Leiden and online for an intensive overview of progress with multiple tasks, all coordinated by the European Society of Cardiology in close partnership with European Federation of National Associations of Orthopaedics and Traumatology and funded by the Horizon 2020 programme. Participants included colleagues from the European Commission, the European Medicines Agency, CEN/CENELEC and a representative from the ISO14155 working group.
In the framework of this meeting, three breakout sessions were organised on medical devices-related issues.
Focusing on the Regulatory aspect in the field of medical devices, Paul Piscoi from the European Commission and Leslie Pibouleau from the European Medicines Agency brought their perspective on the recent development of the Medical Device Regulation shedding the light on its challenges and expectations. They notably pointed to the ongoing work on EUDAMED, expert panels and recent updated guidance document from the medical device coordination group.
The second breakout session addressed the issue of standardisation in the field of medical Devices both at international and the European level. Jennifer Ogbonna from European Center for Standardisation (CEN) provided an overview of the functioning of CEN as well as its recent work in the field of medical devices. The elaboration of standard deriving from an input from members of CEN, i.e. national standardisation institutes, or from a Mandate of the European Commission was presented and discussed by participants. As per International standard, Amie Smirthwaite presented the ongoing work on the annex of ISO 14155.
In the last breakout session, representatives from European Commission, Regulators, Notified Bodies and stakeholders shared their views on how to better cooperate to improve the safety of medical device for the benefit of patients.
You can find the agenda of the meeting here.