Executive Committee

European Academy of Paediatrics

Prof. Berthold Koletzko

President
Munich, Germany

Prof. Liviana da Dalt

EBP Chair
Padova, Italy

Prof. Ann de Guchtenaere

Secretary General
Ghent, Belgium

Dr. Łukasz Dembiński

EAP/EBP Treasurer
Warsaw, Poland

Prof. Adamos Hadjipanayis

Immediate Past President
Nicosia, Cyprus

Prof. Zachi Grossman

Chair Primary Care
Tel Aviv, Israel

Prof. Ketil Strødel

Chair Secondary-Tertiary Care
Oslo, Norway

Dr. Nora Karara

Young EAP Chair
Berlin, Germany

Executive Director Padova, Italy

Dr. Stefano Del Torso

We aim to improve standards in training, service and research and to represent the professional interests of paediatricians in the EU

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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.

EAP Representative: