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 […]
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 […]
