Developing an online risk calculator uncertainty assessment for medical devices with limited evidence
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
25/04/24
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 e…
29/03/24
Alan Fraser, European Society of Cardiology, Scientific Coordinator of CORE-MD and Perla Marang-van de Mheen, Delft University of Technology, talk in …
19/03/24
Alan Fraser, European Society of Cardiology, Scientific Coordinator of CORE-MD and Prof Berthold Koletzko, European Academy of Paediatrics, talk in th…
16/03/24
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 Outco…
12/03/24
Alan Fraser, European Society of Cardiology, Scientific Coordinator of CORE-MD and Ass. Prof. Dr. Per Kjaersgaard-Andersen, EFORT´s Chair EU Affairs C…
29/02/24
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 Me…
15/02/24
Alan Fraser, European Society of Cardiology, Scientific Coordinator of CORE-MD and Richard Holborow, Head of Clinical Compliance BSI Group, talk in th…
05/02/24
The CORE-MD consortium is organising its Final Conference on Friday 15 March 2024 at the De Warande Club in Brussels. This event will gather represent…
03/01/24
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 ne…
08/12/23
Indicative schedule :
18:00 - 18:05 Introduction by Moderator Prof. Alan Fraser, Cardiff University, CORE-MD Scientific Coordinator.18:05 – 18…
30/11/23
Indicative schedule :
17:00-17:05 Introduction by Moderator
Prof. Alan Fraser, Cardiff University, CORE-MD Scientific Coordinator17:05 – 17…
24/11/23
On 24 November 2023, the Biomedical Alliance held its General Assembly gathering representatives from their 36 member scientific societies.
In the …
23/11/23
The CORE-MD Project organised on 21st November 2023, at the BIOMED ALLIANCE new premises in Brussels, a workshop aiming to prepare a ma…
14/11/23
Register today for the upcoming CORE-MD Webinar on "Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Who…
13/11/23
The CORE-MD consortium organised its sixth webinar on high-risk medical devices in the field of cardiovascular disease and diabetes moderate…
06/11/23
The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in p…
03/11/23
Register today for the upcoming CORE-MD Webinar on “What is the evidence for high-risk medical devices in the field of cardiovascular d…
24/10/23
On Tuesday 17 of October 2023, the CORE-MD consortium organised its fifth webinar on The clinical evaluation of Artificial Intelligence and …
10/10/23
Register today for the upcoming CORE-MD Webinar on “The clinical evaluation of Artificial Intelligence and standalone software: keeping the balance be…
03/10/23
Pediatric Research published a new systematic review on clinical trials elaborated by Kathrin Guerlich, Bernadeta Patro-Golab, Paulina Dwora…
26/09/23
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come togeth…
11/09/23
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 th…
07/09/23
The ESC Congress took place in Amsterdam from 25th to 28th August 2023. Several CORE-MD partners presented their results during the various sessions o…
21/08/23
A new Meeting Report has been published from Acta Pediatrica by the authors: Kathrin Guerlich, Bernadeta Patro-Golab, Alex Barnacle, Ul…
08/08/23
In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on he…
01/08/23
The IJHPM (International Journal of Health Policy and Management) has recently published an article review called: Quality and Utility of European Car…
27/07/23
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 …
18/07/23
On Monday 10th of July 2023, the CORE-MD consortium organised its forth webinar on training and education. The REPLAY is now available.…
11/07/23
Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support bo…
29/06/23
Register today for the upcoming CORE-MD Webinar on "Training and education for regulators, for notified bodies and clinicians" taking p…
27/06/23
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 …
05/06/23
The combination of new materials (e.g. in tissue engineering), new methods of testing (e.g. computer-aided modelling, simulation), and new technologie…
01/06/23
This survey aims to assess stakeholders’ awareness about the Guideline on registry-based studies, to identify specific topics requiring clarifica…
25/05/23
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…
21/04/23
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 di…
10/04/23
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).
…
31/03/23
On 13-14 March 2023, Ministers of Health of European Member States discussed, among others, the issue of medical devices.
The Commission provided a…
21/03/23
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).
…
16/03/23
The EU-Chaired 23rd session of the IMDRF will gather international professionals in the medical device regulatory field and provide a valuable opportu…
13/03/23
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 we…
23/02/23
On 6th March 2023, the CORE-MD consortium organises its second webinar addressing the origins and objectives of European regulations for medical devic…
23/02/23
Authors:
Kathrin Guerlich1,2*, Bernadeta Patro-Golab2*, Michael Kammermeier2 , Berthold Koletzko1,2,3, LMU Munich, on behalf of the European Acade…
08/02/23
The CORE-MD Tool offers a strategy for aggregating information from notices of failures to support Postmarket surveillance activities.
This blogpo…
06/02/23
On 30th January, the CORE-MD consortium organised a webinar on Orthopaedic Implants and Medical Device Regulation
You missed the webinar, you can…
19/01/23
CORE-MD methodology to develop a tool aggregating public information on medical devices
The EU Medical Device Regulation 2017/745 defines new rules…
17/01/23
CORE-MD Webinar on Evidence on orthopaedic implants
On 30th January 2023 from 17.00 until 18.15 CET, the CORE-MD consortium organises its first web…
19/12/22
CORE-MD has already reached its halfway point, which was marked on 13 December by most informative presentations to 3 expert reviewers appointed by Ha…
06/12/22
Debates in the legislative and policy-making environment on Artificial Intelligence (AI) have gradually concerned the medical device field. Where do A…
02/12/22
Biomed Alliance represents 36 biomedical Societies in Europe
Continuing challenges for the implementation of the EU Medical Devices Regulation (MDR…
09/11/22
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…
31/10/22
MDCG guidance document on authorised representatives
Where the manufacturer of a device is not established in a Member State, the device may onlybe…
10/09/22
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 r…
07/09/22
In the framework of the annual congress of the European Society of Cardiology (Barcelona, Friday 26 - Monday 29 August), a dedicated session on CORE-M…
29/08/22
Biomed Alliance's survey on availability of medical devices
Further to its June press release, the Biomed Alliance issued a survey to assess whethe…
06/08/22
According to Article 100 of Regulation (EU) 2017/746, the European Commission may designate EU reference laboratories (EURLs) for high-risk in vi…
06/06/22
In the framework of the BioMed Alliance In Vitro Diagnostics (IVD) Task Force, experts on in vitro diagnostic medical devices provided their analysis …
25/05/22
The European Commission issued its Implementing Decision (EU) 2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 as regards harmon…
18/05/22
A new survey was launched by CORE-MD partners, aiming to assess educational needs of clinicians, notified bodies and regulators related to regulatory …
15/05/22
Participants in CORE-MD Project Board Meeting - Leiden 25-26 April 2022
Members of the CORE-MD consortium met recently for the first time in person…
13/05/22
RAPS meeting in Amsterdam - 12 May 2022
CORE-MD project was presented at the Regulatory Affairs Professionals Society in Amsterdam. Euro Convergenc…
17/04/22
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…
02/03/22
The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of 1 March…
18/02/22
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 c…
01/02/22
Under the leadership of the Department of Cardiology, Bern University Hospital, CORE-MD partners work on a protocol for a systematic review to critica…
27/01/22
CORE-MD work package and task leaders got together online on 21st January 2022 fostering synergies between the CORE-MD researchers. This meeting aimed…
19/01/22
As from 17 January 2022, the new revised Commission's sectorial webpages on Medical Devices are available from the Directorate-General for Health and …
13/01/22
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…
10/01/22
Dear colleague,Welcome to the first edition of the CORE-MD newsletter. CORE-MD is a Horizon 2020 project which brings together 22 partners,…
10/11/21
The CORE-MD international Advisory Board chaired by Paul Piscoi (European Commission) met on 10 November 2021 for the first time. The Board includes m…
26/05/21
Today, the new EU medical device regulation comes into force, increasing the requirements for clinical evidence on high-risk medical devices. &nb…
17/04/21
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 ens…
16/04/21
The methods for evaluating high-risk medical devices are set to be reviewed in the EU-funded CORE-MD project,1 which holds its kick-off meeting today.…
