After having ISSOP’s 2017 Budapest meeting’s position statement on migrant child health – widely known as the Budapest Declaration – endorsed by many paediatric societies, the European Academy of Paediatrics was invited this March to participate in the ad-hoc working group. Established within ISSOP, this group aims to turn recommendations of the Declaration into real actions over the coming years.
The detailed Action Plan of the working group, built upon the key elements of the Declaration, identifies as its main objectives:
These objectives are all required to fulfil purposes of the source document.
Led by Professor Charles Oberg from the University of Minnesota, members of the group presenting diverse affiliation and professional interests recently decided to form subgroups in the following areas: clinical care, health systems, policy development and best practices. This was done following the Action Plan’s Timeline as the next process objective.
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.
