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 […]
Upcoming CORE-MD Webinar
Register today for the upcoming CORE-MD Webinar on “Training and education for regulators, for notified bodies and clinicians“ taking place on Monday 10 July 2023 from 17:00 to 18:15 CET. Moderator: Claudia Wild, AIHTA/ CORE-MD The Webinar will address the following topics: Learning Objectives: Please help us to share knowledge within the scientific community and forward this announcement to your […]
Open letter to Commissioner Stella Kyriakides to secure access to essential medical devices for children
The original goals of the EU Medical Device Regulation 745/2017 (EU MDR), i.e. to strengthen clinical evaluation and safety particularly of high-risk medical devices, are widely supported. However, the application of the EU MDR has hugely increased the time and cost associated with bringing medical devices to market or maintaining them on the market. The […]
Perceived training needs for regulators, notified bodies and clinicians: result of CORE-MD survey
The combination of new materials (e.g. in tissue engineering), new methods of testing (e.g. computer-aided modelling, simulation), and new technologies (e.g. neuroprosthetics, artificial intelligence) means that regulators, staff in Notified Bodies, and clinical experts such as those acting as advisers to Notified Bodies or as members of Expert Panels, must keep pace with technological developments and […]
Survey on the EMA Guideline on registry-based studies
This survey aims to assess stakeholders’ awareness about the Guideline on registry-based studies, to identify specific topics requiring clarification, and to understand training needs. The Guideline was endorsed by the Committee for Medicinal Products for Human Use (CHMP) and published on the European Medicines Agency (EMA) website in October 2021 following two extensive public consultations. It […]