In early September, EAP took to social media to voice the need to better support children and young people affected by Non-Communicable Diseases (NCDs). EAP representatives shared their messages on the need for concerted and multisectoral actions to tackle NCDs and their risk factors.
In addition to the social media campaign, Young EAP Members and EAP’s Executive Director Stefano Del Torso penned a special article on EPHA’s website, in which they analysed the main NCDs causes and urged the EU to tackle the burden of NCDs from an early age.
This initiative was carried out in support of the Global Week for Action on NCDs, a worldwide event spearheaded by the NCD Alliance and featuring health actors such as EPHA, ahead of the UN High-Level Meeting on NCDs.
New ways to test high-risk medical devices.
Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.
It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.
