Association Européenne pour l’Enseignement de la Pédiatrie
ECPCP
European Confedereation Primary Care Pediatricians
EPHA
European Public Health Alliance
ESPNIC
European Society for Paediatric and Neonatal Intensive Care
ESPR
European Society Paediatric Research
ESPRad
European Soceity Paediatric Radiology
EUPHA
Child and Adolescent Health Section
IPA
International Pediatric Association
ISSOP
International Society for Social Pediatrics and Child Health
PNAE
Paediatric Nursing Associations of Europe
JUEMS
Japan Pediatric Society
UNEPSA/EPA
European Pediatric Association/Union of National European Paediatric Societies and Associations
JPEDS
Japan Pediatric Society
J UEMS
Section of Child and Adolescent Psychiatry UEMS
VIVI
Vienna Vaccine Safety Initiative (ViVi)
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Core-MD Project
Coordinating Research and Evidence for Medical Devices (CORE-MD)
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.