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 […]
CORE-MD project discussed at EFORT Congress, Vienna 24-26 May 2023
The annual meeting of European Orthopaedic Surgeons takes place in Vienna from 24th until 26th May 2023. Tom Melvin, Perla Marang-van de Mheen, Rob Nelissen, Anne Lübbeke-Wolff and Richard Holborow were panelist in a dedicated session on quality and safety of implants took place in the framework of this EFORT Congress. Several CORE-MD partners presented […]
CORE-MD Project Board meeting – Leuven 17-18 April 2023
On 17th and 18th April 2023, the CORE-MD consortium met at the Faculty Club of the Catholic University of Leuven to review progress made, share and discuss results of studies. The Project Board meeting is the annual meeting of partners involved in CORE-MD. In this respect, representatives from Regulators, Notified Bodies, Scientific Societies, Patients, Universities […]
Webinar on Objective Performance criteria now available in replay
On Monday 3rd April 2023 from 17.00 until 18:15 (CET), the CORE-MD consortium organised its third webinar on objective performance criteria (OPC). Moderated by Prof. Alan Fraser, from the European Society of Cardiology, and Prof. Ewout Steyerberg, from Leiden University, the webinar addressed the issue of the origins, the methods and the clinical utility of objective performance criteria. In […]
Employment, Social Policy, Health and Consumer Affairs Council discuss medical devices
On 13-14 March 2023, Ministers of Health of European Member States discussed, among others, the issue of medical devices. The Commission provided an update on the implementation of the medical devices regulations and the presidency, together with the Commission, informed delegations about the negotiations for an international agreement on pandemic prevention, preparedness and response. In its policy […]
CORE-MD webinar: Objective Performance Criteria
On Monday 3rd April 2023 from 17.00 until 18:15 (CET), the CORE-MD consortium organises its third webinar on objective performance criteria (OPC). Moderated by Prof. Alan Fraser, from the European Society of Cardiology, and Prof. Ewout Steyerberg, from Leiden University, the webinar will address the issue of the origins, the methods and the clinical utility […]
International Medical Device Regulators Forum – IMDRF23 – Join the Open Stakeholder Session, Brussels, 27 – 28 March 2023
The EU-Chaired 23rd session of the IMDRF will gather international professionals in the medical device regulatory field and provide a valuable opportunity for exchange between participating authorities, industry and clinical associations. Several issues discussed are already being worked on by the CORE-MD consortium such as post-market surveillance, real-world evidence, criteria to evaluation medical devices. On Day 1, […]
CORE-MD webinar replay: the origins and the objectives of the Medical Device Regulation
On 6th March 2023, the CORE-MD consortium organised a webinar on the origins and the objectives of the Medical Device Regulation (Alan Fraser). The webinar also addressed the issue of regulatory science (Tom Melvin). Prof. Rob Nelissen presented the role of the expert panels while Dr Paul Piscoi highlighted the role of clinicians from the […]
Second CORE-MD webinar: The origins and objectives of European regulations for medical devices
On 6th March 2023, the CORE-MD consortium organises its second webinar addressing the origins and objectives of European regulations for medical devices. Prof Alan Fraser, from the European Society of Cardiology will provide a historical view on European legislation on Medical Devices. Ass. Prof. Tom Melvin, from Trinity College, Dublin, will cover the emerging discipline […]
