CORE-MD work on Paediatric devices presented at the International Medical Device Regulators Forum
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
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.…
