Evidence from clinical trials on high-risk medical devices in children: a scoping review
Pediatric Research published a new systematic review on clinical trials elaborated by Kathrin Guerlich, Bernadeta Patro-Golab, Paulina Dworakowski, Alan G. Fraser, Michael Kammermeier, Tom Melvin & Berthold Koletzko. Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children. Within the CORE-MD […]
CORE-MD work on Paediatric devices presented at the International Medical Device Regulators Forum
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonisation and convergence. IMDRF produces guidance documents aiming […]
Lack of published evidence for high-risk medical devices in Europe – new findings from CORE-MD
Investigators from the CORE-MD Project revealed at the end of August in the European Heart Journal that a majority of new high-risk medical devices that are used to treat heart disease have been released to the market in the European Union (EU) with insufficient evidence from clinical trials. That means that too little information about […]
CORE-MD partners presented their results at the ESC Congress
The ESC Congress took place in Amsterdam from 25th to 28th August 2023. Several CORE-MD partners presented their results during the various sessions of this major Scientific Congress. 𝗣𝗿𝗼𝗳 𝗔𝗹𝗮𝗻 𝗙𝗿𝗮𝘀𝗲𝗿, chairperson of the ESC TV 📺 Special Session “Clinical evidence for high-risk devices“, engaged in an insightful discussion with Stephen Windecker and Perla Marang-van de Mheen who shared […]
European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children
A new Meeting Report has been published from Acta Pediatrica by the authors: Kathrin Guerlich, Bernadeta Patro-Golab, Alex Barnacle, Ulrich Baumann, Andreas Eicken, Alan G. Fraser, Dariusz Gruszfeld, Nikolaus A. Haas, Anneliene H. Jonker, Michael Kammermeier, Damien Kenny, Sanja Kolaček, Risto Lapatto, Ian Maconochie, Silke Mader, Gearóid McGauran, Tom Melvin, Oliver Muensterer, Paul Piscoi, Alberto Romano, Amulya K. Saxena, Dominik T. Schneider, Mark A. Turner, Johan Vande Walle, Berthold Koletzko, the European Academy of Paediatrics. Abstract Several high-risk medical devices […]
Public consultation on WHO guidance for best practices for clinical trials
In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, in which one action requested of the Director-General was to develop WHO guidance on best practices for clinical trials. In line with this request, the WHO is launching […]
Systematic Review of Cardiovascular and Orthopaedic Registries: new publication
The IJHPM (International Journal of Health Policy and Management) has recently published an article review called: Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review. Authors: Lotje A. Hoogervorst, Timon H. Geurkink, Anne Lübbeke, Sergio Buccheri, Jan W. […]
CORE-MD video: Surveying the landscape
As part of its work, CORE–MD reviewed methods for evaluating high-risk medical devices, in order to translate expert evidence into advice for EU regulators and to recommend an appropriate balance between innovation, safety, and clinical effectiveness. “It’s very important that regulatory institutes know exactly how to evaluate implants and the CORE-MD project tried by this to […]
New Webinar available for REPLAY
On Monday 10th of July 2023, the CORE-MD consortium organised its forth webinar on training and education. The REPLAY is now available. Moderated by Claudia Wild from AIHTA, the learning objectives of the webinar are: The aim of the CORE_MD activities is to identify the needs for advanced training for the assessment of high-risk medical devices, in the context […]
Use of real-world evidence in regulatory decision making
Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties and national competent authorities. These are some of the findings of a report published last month on the experience EMA has gained in conducting studies with real-world […]
