News

Jasper van Egeraat, Bas Penning de Vries, Ewout Steyerberg High risk devices may be approved based on limited evidence from underpowered clinical studies. They may have a higher risk than commonly accepted. While an observed event rate may seem favourable, regulators, healthcare professionals and patients should be aware that there

On 15th March 2024, the CORE-MD consortium organised its Final Conference in Brussels. Gathering a large number of partners involved in CORE-MD, the event also attracted various stakeholders to discuss the challenges of the implementation of the Medical Device Regulation In the introductory purposes, Prof. Alan Fraser from the ESC

Alan Fraser, European Society of Cardiology, Scientific Coordinator of CORE-MD and Perla Marang-van de Mheen, Delft University of Technology, talk in this CORE-MD Podcast about Real-world evidence on the performance of High-Risk Medical Devices. Also, do not miss our past CORE-MD webinar on a similar topic: “IT tools for regulatory

Alan Fraser, European Society of Cardiology, Scientific Coordinator of CORE-MD and Prof Berthold Koletzko, European Academy of Paediatrics, talk in this CORE-MD Podcast about Providing Medical Devices for children. Also, do not miss our past CORE-MD webinar on “Providing high-risk medical devices for children – problems and proposals“.

On 25 March 2024, from 17.00 CET until 18.15, the CORE-MD consortium organises its thirteenth free webinar entitled “The use of Patient Reported Outcome Measures in clinical evaluation of medical devices“. The indicative schedule is as follows: 17:00 – 17:05 | Introduction by Moderator | Prof. Alan Fraser, BioMed Alliance,

On 4 March 2024, from 17.00 CET until 18.15, the CORE-MD consortium organises its twelve free webinar entitled “The use of Patient Reported Outcome Measures in clinical evaluation of medical devices”. The indicative schedule is as follows: The learning objectives are:

On 8th January 2024, from 17.00 CET until 18.15, the CORE-MD consortium organises its tenth free webinar entitled “Early clinical investigations of new high-risk medical devices – how lack of transparency inhibits improvement in evaluation”. The learning objectives are: Join us for free and register here

Indicative schedule : 18:00 – 18:05 Introduction by Moderator Prof. Alan Fraser, Cardiff University, CORE-MD Scientific Coordinator.18:05 – 18:15 Systematic Review of evidence for high-risk medical devices in Children | Kathrin Guerlich. Child Health Foundation (Stiftung Kindergesundheit), c/o Dr. von Hauner Children’s Hospital, Munich, Germany.18:15 – 18:25 Disappearing Orphan Devices |

Indicative schedule : 17:00-17:05 Introduction by Moderator Prof. Alan Fraser, Cardiff University, CORE-MD Scientific Coordinator 17:05 – 17:25 Exploiting IT tools to retrieve alerts and reports of high-risk medical devices – presenting the CORE-MD search engine, Prof. Enrico Caiani, Politecnico Di Milano 17:25 – 17:35 The EMA’s expert panels role in

On 24 November 2023, the Biomedical Alliance held its General Assembly gathering representatives from their 36 member scientific societies. In the framework of this meeting, a dedicated session, chaired by Prof. Elisabeth Mcintyre, Biomedical Alliance President elect, on real-world evidence and registries was organised to present the challenges of the

The CORE-MD Project organised on 21st November 2023, at the BIOMED ALLIANCE new premises in Brussels, a workshop aiming to prepare a matrix of recommended methodologies for the clinical evaluation of high-risk medical devices. Among the 30 regulatory guidance documents, the 12 ISO Standards and the 4 documents from other Research Consortia, there

Register today for the upcoming CORE-MD Webinar on “Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Whom?“ taking place on Monday 27 November 2023 from 17:00 to 18:15 CET. Moderator:  Prof. Alan Fraser The Webinar will address the following topics: Learning Objectives:

The CORE-MD consortium organised its sixth webinar on high-risk medical devices in the field of cardiovascular disease and diabetes moderated by Prof. Robert Byrne, Director of Cardiology and Director of the Cardiovascular Research Institute at Mater Private Network, Dublin, Ireland. Learning Objectives: Visit our webinar web page to see the upcoming webinars and

The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force in May 2021 of the EU Medical Device Regulation. Authors: Anne Lübbeke, Christophe Combescure, Christophe Barea, Amanda Inez Gonzalez, Keith

Register today for the upcoming CORE-MD Webinar on “What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes? Results and implications of the CORE-MD systematic reviews“ taking place on Monday 06 November 2023 from 17:00 to 18:15 CET. Moderator: Prof. Robert Byrne. The Webinar will address the following topics: Learning Objectives:

On Tuesday 17 of October 2023, the CORE-MD consortium organised its fifth webinar on The clinical evaluation of Artificial Intelligence and standalone software. The REPLAY is now available. Moderated by Em. Prof. Frank Rademakers, the learning objectives of the webinar were: Visit our webinar web page to see the upcoming webinars and to download the

Register today for the upcoming CORE-MD Webinar on “The clinical evaluation of Artificial Intelligence and standalone software: keeping the balance between benefit and risk.“ taking place on Monday 17 October 2023 from 17:00 to 18:30 CET. Moderator: Claudia Wild, AIHTA/ CORE-MD The Webinar will address the following topics: Learning Objectives: Please help us to share knowledge within

Pediatric Research published a new systematic review on clinical trials elaborated by Kathrin Guerlich, Bernadeta Patro-Golab, Paulina Dworakowski, Alan G. Fraser, Michael Kammermeier, Tom Melvin & Berthold Koletzko. Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonisation and

Investigators from the CORE-MD Project revealed at the end of August in the European Heart Journal that a majority of new high-risk medical devices that are used to treat heart disease have been released to the market in the European Union (EU) with insufficient evidence from clinical trials. That means

The ESC Congress took place in Amsterdam from 25th to 28th August 2023. Several CORE-MD partners presented their results during the various sessions of this major Scientific Congress. 𝗣𝗿𝗼𝗳 𝗔𝗹𝗮𝗻 𝗙𝗿𝗮𝘀𝗲𝗿, chairperson of the ESC TV 📺 Special Session “Clinical evidence for high-risk devices“, engaged in an insightful discussion with Stephen

A new Meeting Report has been published from Acta Pediatrica by the authors: Kathrin Guerlich, Bernadeta Patro-Golab, Alex Barnacle, Ulrich Baumann, Andreas Eicken, Alan G. Fraser, Dariusz Gruszfeld, Nikolaus A. Haas, Anneliene H. Jonker, Michael Kammermeier, Damien Kenny, Sanja Kolaček, Risto Lapatto, Ian Maconochie, Silke Mader, Gearóid McGauran, Tom Melvin, Oliver Muensterer, Paul Piscoi, Alberto Romano, Amulya K. Saxena, Dominik T. Schneider, Mark A. Turner, Johan Vande Walle, Berthold Koletzko, the European Academy of Paediatrics.

In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, in which one action requested of the Director-General was to develop WHO guidance on best practices for clinical trials. In line with this

The IJHPM (International Journal of Health Policy and Management) has recently published an article review called: Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review. Authors: Lotje A. Hoogervorst, Timon H. Geurkink, Anne

As part of its work, CORE–MD reviewed methods for evaluating high-risk medical devices, in order to translate expert evidence into advice for EU regulators and to recommend an appropriate balance between innovation, safety, and clinical effectiveness. “It’s very important that regulatory institutes know exactly how to evaluate implants and the CORE-MD

On Monday 10th of July 2023, the CORE-MD consortium organised its forth webinar on training and education. The REPLAY is now available. Moderated by Claudia Wild from AIHTA, the learning objectives of the webinar are: The aim of the CORE_MD activities is to identify the needs for advanced training for the assessment of high-risk

Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties and national competent authorities. These are some of the findings of a report published last month on the experience EMA has gained

Register today for the upcoming CORE-MD Webinar on “Training and education for regulators, for notified bodies and clinicians“ taking place on Monday 10 July 2023 from 17:00 to 18:15 CET. Moderator: Claudia Wild, AIHTA/ CORE-MD The Webinar will address the following topics: Learning Objectives: Please help us to share knowledge within the scientific community and

The original goals of the EU Medical Device Regulation 745/2017 (EU MDR), i.e. to strengthen clinical evaluation and safety particularly of high-risk medical devices, are widely supported. However, the application of the EU MDR has hugely increased the time and cost associated with bringing medical devices to market or maintaining

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

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

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

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

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

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

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

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

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

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,

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,

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

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,

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

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

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

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

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

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

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

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

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

Further to its June press release, the Biomed Alliance issued a survey to assess whether clinicians in different fields are already experiencing issues around the availability of certain medical devices, which devices are affected and whether they expect to experience any issues in the future. Reports from clinicians, the European

According to Article 100 of Regulation (EU) 2017/746, the European Commission may designate EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs).  The EURLs have two main categories of tasks: advisory ones and those related to market access of class D devices. For market access of class D

In the framework of the BioMed Alliance In Vitro Diagnostics (IVD) Task Force, experts on in vitro diagnostic medical devices provided their analysis on the challenges of IVDR. Several experts are also CORE-MD partners. With the implementation of Regulation (European Union [EU]) 2017/746 on in vitro diagnostic medical devices (IVDR),

The European Commission issued its Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for quality management systems, sterilisation and application of risk management to medical devices. According to the Medical Device Regulation, devices that are in conformity with the relevant harmonised standards,

A new survey was launched by CORE-MD partners, aiming to assess educational needs of clinicians, notified bodies and regulators related to regulatory affairs. The survey takes around 10-15 minutes to complete and is open until 10th June. This survey will help to assess what sort of knowledge clinicians have on

Members of the CORE-MD consortium met recently for the first time in person. More than 50 investigators gathered at the University of Leiden and online for an intensive overview of progress with multiple tasks, all coordinated by the European Society of Cardiology in close partnership with European Federation of National

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

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

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

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

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

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

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 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

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

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 CORE-MD Kick-Off Meeting took place virtually on Friday 16 April 2021 from 14:00 to 17:00 CEST. It brought together all consortium partners to ensure a common understanding of the project goals, tasks, planning, and the roles and responsibilities of each partner and to launch the coordination, the planned collaborations