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 […]
Medical Device for children
Authors: Kathrin Guerlich1,2*, Bernadeta Patro-Golab2*, Michael Kammermeier2 , Berthold Koletzko1,2,3, LMU Munich, on behalf of the European Academy of Paediatrics Affiliations: 1 – Stiftung Kindergesundheit, c/o Dr. von Hauner Children’s Hospital2 – Division of Metabolic and Nutritional Medicine, Department of Pediatrics, Dr. von Hauner Children’s Hospital, LMU University Hospital Munich, Germany 3 – European Academy […]
Post-Market Surveillance tool: input from CORE-MD
The CORE-MD Tool offers a strategy for aggregating information from notices of failures to support Postmarket surveillance activities. This blogpost was written by Prof. Enrico Caiani and Yijun Ren with the support of Fernanda Santana The recent scientific article “Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures […]