CORE-MD presented at the Regulatory Affairs Professionals Society in Amsterdam
CORE-MD project was presented at the Regulatory Affairs Professionals Society in Amsterdam. Euro Convergence is the premier annual event for European regulatory professionals. This year’s event drew more than 500 participants from six continents and 33 countries. Attendees gathered for three days of education sessions, expert presentations and panel discussions curated exclusively by European regulatory […]
Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)2 was adopted by the Council and the European Parliament in April 2017. This new framework sets high standards of quality andsafety for medical devices and aims at ensuring the […]
Regulation on EMA’s extended mandate becomes applicable
The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of 1 March 2022. EMA is now responsible for monitoring medicine shortages that might lead to a crisis situation, as well as reporting shortages of critical medicines during a crisis. The Agency will also coordinate responses of EU / EEA countries to shortages […]
CORE-MD presented at the 6th EUCROF Congress
Held in Madrid on 6-7 February 2022, the 6th EUCROF Congress “Clinical Trials in a New Era” proved to be an important forum to discuss changes which clinical research is currently facing. EUCROF, the European Contract Research Organization Federation, is a non-profit organization founded in 2005 with the aim to promote Clinical Research by improving […]
CORE-MD protocol for a systematic review of methodologies
Under the leadership of the Department of Cardiology, Bern University Hospital, CORE-MD partners work on a protocol for a systematic review to critically evaluate the methodologies applied in clinical investigations to evaluate high-risk medical devices in cardiovascular medicine. Experts should advise on the evaluation process of high-risk medical devices in clinical investigations. As a matter […]
Coordination Group Meeting of CORE-MD researchers
CORE-MD work package and task leaders got together online on 21st January 2022 fostering synergies between the CORE-MD researchers. This meeting aimed at focusing particularly on the progress of methods used to generate clinical evidence for high-risk CE-marked cardiovascular, orthopaedic and diabetic medical devices. The objective will be to carry out cross-cutting qualitative analysis between […]
New Commission’s webpages on Medical Devices
As from 17 January 2022, the new revised Commission’s sectorial webpages on Medical Devices are available from the Directorate-General for Health and Food Safety (DG SANTE)’s Public Health website. Within the transformation and upgrade of the Public Health website, the sectorial webpages on medical devices have been aligned with the Commission’s corporate design. This includes the possibility to […]
An IT tool for assisting Medical Devices Post-Market Surveillance
This Master’s Thesis at the Politecnico di Milano is the first formal academic output linked to the CORE-MD project. This pilot study focused on the development of an IT tool for assisting medical devices post-market surveillance. Interestingly, this tool aims to retrieve and aggregate public information relevant to safety notices from the official website of […]
CORE-MD January Newsletter
Dear colleague, Welcome to the first edition of the CORE-MD newsletter. CORE-MD is a Horizon 2020 project which brings together 22 partners, led by ESC in close cooperation with EFORT. CORE-MD will review the methods used for clinical evaluation and monitoring of high-risk medical devices, and recommend how standards and new study designs can be developed. […]
CORE-MD Advisors discuss about MDR practices around the globe
The CORE-MD international Advisory Board chaired by Paul Piscoi (European Commission) met on 10 November 2021 for the first time. The Board includes medical device specialists from various sectors, public and private organisations and continents to complement and reflect on the project activities. The first meeting focussed on (i) presenting the roots of CORE-MD, the […]
