CORE-MD first webinar available in replay

On 30th January, the CORE-MD consortium organised a webinar on Orthopaedic Implants and Medical Device Regulation You missed the webinar, you can watch it here! The presentation of Prof. Anne Lübbeke-Wolff is available here The presentation of Dr Keith Tucker is available here To remain informed of updates on CORE-MD, do not hesitate to subscribe […]

Promising results for CORE‑MD Support Tool aggregating Information on Medical Devices

The EU Medical Device Regulation 2017/745 defines new rules for the certification and post-market surveillance of medical devices (MD), including an additional review by Expert Panels of clinical evaluation data for high-risk MD if reports and alerts suggest possibly associated increased risks. Within the EU-funded CORE-MD project, a tool was developed to support such process […]

First CORE-MD webinar: Orthopaedic implants and European Medical Device Regulations

On 30th January 2023 from 17.00 until 18.15 CET, the CORE-MD consortium organises its first webinar on Orthopaedic implants and European medical device regulations. Prof. Anne Lübbeke-Wolff from the Universities of Geneva and Oxford and Dr Keith Tucker from the Orthopaedic Data Evaluation Panel are the two panelists of the webinar. It will be moderated […]

CORE-MD Christmas Newsletter

CORE-MD has already reached its halfway point, which was marked on 13 December by most informative presentations to 3 expert reviewers appointed by HaDEA. Already, results have been submitted for publication and a huge amount of work has been done. For more information, read the full newsletter Should you wish to receive the CORE-MD newsletter, please […]

Artificial Intelligence and Medical Devices Regulation. Discussing the legal framework and the ethical challenges within the CORE-MD project

Debates in the legislative and policy-making environment on Artificial Intelligence (AI) have gradually concerned the medical device field. Where do AI-based medical devices regulation stand in the EU? This blog post gives a short and non-exhaustive overview of the legal and ethical aspects of AI-based medical devices that are being researched and discussed in the […]

Biomed Alliance’s call for action on essential medical devices

Continuing challenges for the implementation of the EU Medical Devices Regulation (MDR) will be discussed by health ministers during the EPSCO meeting on 9 December. The BioMed Alliance believes that a variety of measures is necessary. It will support an extension of the recertification deadline of 26 May 2024, on condition that standards for clinical evidence […]

CORE-MD expert meeting the Clinical Investigation and Evaluation Working Group

On 7th November, the experts involved in CORE-MD took part in the workshop organised by the EU WG Clinical Investigation and Evaluation (CIE). The aim of the meeting was to present to the European regulators the initial results of CORE-MD and reflect on the current challenges derived from the implementation of the Medical Devices Regulation. […]

New MDCG guidance document

Where the manufacturer of a device is not established in a Member State, the device may onlybe placed on the Union marketif the manufacturer designates a sole authorised representative. The term ‘device’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical […]

CORE-MD at  ISAR conference

Within the CORE-MD Consortium, Drs Lotje A. Hoogervorst,MD, PhD student is working with Dr Perla J. Marang-van de Mheen on aggregating insights from registries, big data and clinical experience (Task 3.1). During the last  International Society of Arthroplasty Registry conference in Dublin, Drs. Hoogervorst, gave two lectures on “Quality of European orthopaedic registries for the regulatory evaluation of medical […]

CORE-MD TV session at ESC Congress

In the framework of the annual congress of the European Society of Cardiology (Barcelona, Friday 26 – Monday 29 August), a dedicated session on CORE-MD was organised. Three active partners in CORE-MD discussed about clinical trials for medical device and presented its benefits for regulators. Prof. Piotr Szymanski (Chairman of the EU Regulatory Affairs Committee […]