A dedicated session on medical devices and the contribution of CORE-MD at the Biomedical Alliance General Assembly
On 24 November 2023, the Biomedical Alliance held its General Assembly gathering representatives from their 36 member scientific societies. In the framework of this meeting, a dedicated session, chaired by Prof. Elisabeth Mcintyre, Biomedical Alliance President elect, on real-world evidence and registries was organised to present the challenges of the implementation of the Medical Device […]
CORE-MD workshop on high-risk medical devices
The CORE-MD Project organised on 21st November 2023, at the BIOMED ALLIANCE new premises in Brussels, a workshop aiming to prepare a matrix of recommended methodologies for the clinical evaluation of high-risk medical devices. Among the 30 regulatory guidance documents, the 12 ISO Standards and the 4 documents from other Research Consortia, there are gaps that have been […]
Upcoming CORE-MD Webinar on Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Whom?”
Register today for the upcoming CORE-MD Webinar on “Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Whom?“ taking place on Monday 27 November 2023 from 17:00 to 18:15 CET. Moderator: Prof. Alan Fraser The Webinar will address the following topics: Learning Objectives:
CORE-MD Webinar on the high-risk medical devices in the field of cardiovascular disease and diabetes available for REPLAY
The CORE-MD consortium organised its sixth webinar on high-risk medical devices in the field of cardiovascular disease and diabetes moderated by Prof. Robert Byrne, Director of Cardiology and Director of the Cardiovascular Research Institute at Mater Private Network, Dublin, Ireland. Learning Objectives: Visit our webinar web page to see the upcoming webinars and to download the presentations of […]
A systematic review of the peer-reviewed medical literature
The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force in May 2021 of the EU Medical Device Regulation. Authors: Anne Lübbeke, Christophe Combescure, Christophe Barea, Amanda Inez Gonzalez, Keith Tucker, Per Kjærsgaard-Andersen, Tom Melvin, […]
Upcoming CORE-MD Webinar on high-risk medical devices in the field of Cardiovascular Disease and Diabetes
Register today for the upcoming CORE-MD Webinar on “What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes? Results and implications of the CORE-MD systematic reviews“ taking place on Monday 06 November 2023 from 17:00 to 18:15 CET. Moderator: Prof. Robert Byrne. The Webinar will address the following topics: Learning Objectives:
CORE-MD Webinar on AI available for REPLAY
On Tuesday 17 of October 2023, the CORE-MD consortium organised its fifth webinar on The clinical evaluation of Artificial Intelligence and standalone software. The REPLAY is now available. Moderated by Em. Prof. Frank Rademakers, the learning objectives of the webinar were: Visit our webinar web page to see the upcoming webinars and to download the presentations of the panelists.
Upcoming CORE-MD Webinar on clinical evaluation of Artificial Intelligence
Register today for the upcoming CORE-MD Webinar on “The clinical evaluation of Artificial Intelligence and standalone software: keeping the balance between benefit and risk.“ taking place on Monday 17 October 2023 from 17:00 to 18:30 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 […]
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 […]
