Core MD

The BioMed Alliance is a partner in the CORE -MD project, a European project funded under Horizon 2020 that contributes to evidence-based decision making for medical devices.

The project, which was launched in April 2021, ran until March 2024 and aimed at translating expert knowledge into advice for regulatory guidance and building expertise and Regulatory Science in the clinical community. It reviewed methodologies for the clinical evaluation of high-risk medical devices and recommended new designs to set an appropriate balance between innovation, safety, and clinical effectiveness.

BioMed Alliance was co-leading work package 4 “Network and Community Building” and thus played an important role in the dissemination of the results, while also ensuring input from its members was included in different parts of the project.

The consortium was led by ESC and EFFORT and composed of a mix of medical societies, patient organisations, national regulatory agencies, academic institutions, notified bodies and other health stakeholders.

Work packages:

WP5 Project management
WP1 Understanding methods used to generate clinical evidence for high-risk medical devices
WP2 Strengthening evidence for high-risk medical devices: New methods for generating clinical evidence.
WP3 Extracting maximal value from medical device registries and real-world evidence.
WP4 Networking and community building

For more information and results see the CORE-MD website.

‘This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 965246.’

Highlights

Developing an online risk calculator uncertainty assessment for medical devices with limited evidence

Jasper van Egeraat, Bas Penning de Vries, Ewout Steyerberg High risk devices may be approved based on limited evidence from underpowered clinical studies. They may have a higher risk than commonly accepted. While an observed event rate may seem favourable, regulators, healthcare professionals and patients should be aware that there is considerable uncertainty due to […] The post Developing an online risk calculator uncertainty assessment for medical devices with limited evidence appeared first on CORE-MD.

01 June 2024Read more

CORE-MD Podcast – Real-world evidence on the performance of High-Risk Medical Devices

Alan Fraser from the European Society of Cardiology and Scientific Coordinator of CORE-MD, together with Perla Marang-van de Mheen from Delft University of Technology, delve into the critical topic of real-world evidence (RWE) in their latest CORE-MD Podcast. This podcast complements the recent CORE-MD webinar titled, “IT tools for regulatory science: aggregating available data for high-risk medical devices”, where the role of innovative IT tools in regulatory science and the aggregation of medical device data was discussed in depth. The post CORE-MD Podcast – Real-world evidence on the performance of High-Risk Medical Devices appeared first on CORE-MD.

29 March 2024Read more

CORE-MD Podcast – Providing Medical Devices for children

In this CORE-MD Podcast, Alan Fraser from the European Society of Cardiology, and Scientific Coordinator of CORE-MD, as well as Prof Berthold Koletzko from the European Academy of Paediatrics, talk about Providing Medical Devices for children. Also, do not miss our past CORE-MD webinar on “Providing high-risk medical devices for children – problems and proposals“. The post CORE-MD Podcast – Providing Medical Devices for children appeared first on CORE-MD.

19 March 2024Read more

CORE–MD Final Conference

The CORE-MD consortium is organising its Final Conference on Friday 15 March 2024 at the De Warande Club in Brussels. This event will gather representatives from regulators, notified bodies, researchers, industry but also patients and healthcare professionals. It will notably contribute to share its insights on the clinical evaluation of high-risk medical devices based on […] The post CORE–MD Final Conference appeared first on CORE-MD.

15 March 2024Read more

Upcoming Webinar on Patient Reported Outcome Measures for medical devices

On 4 March 2024, from 17.00 CET until 18.15, the CORE-MD consortium organises its twelve free webinar entitled “The use of Patient Reported Outcome Measures in clinical evaluation of medical devices”. The indicative schedule is as follows: The learning objectives are: The post Upcoming Webinar on Patient Reported Outcome Measures for medical devices appeared first on CORE-MD.

04 March 2024Read more

Upcoming Webinar on Early Clinical Investigation of Medical Devices

On 8th January 2024, from 17.00 CET until 18.15, the CORE-MD consortium organises its tenth free webinar entitled “Early clinical investigations of new high-risk medical devices – how lack of transparency inhibits improvement in evaluation”. The learning objectives are: Join us for free and register here The post Upcoming Webinar on Early Clinical Investigation of Medical Devices appeared first on CORE-MD.

03 January 2024Read more