Webinars
The Notified Body’s Role & The Conformity Assessment Process
The CORE-MD consortium organised its thirteenth and last webinar on “The Notified Body’s Role & The Conformity Assessment Process” moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD
Learning objectives:
- To understand the role of Notified Bodies in the evaluation process of Medical Devices.
- To understand the conformity assessment process performed by Notifies Bodies.
- To discuss the role and challenges of Notifies Bodies in the implementation of the Medical Device Regulation.
The presentation from Richard Holborow, is available here.
The presentation from Suzanne Halliday, is available here.
The presentation from Françoise Schlemmer, is available here.
Patient Reported Outcome Measures
The CORE-MD consortium organised its twelfth webinar on “Patient Reported Outcome Measures” moderated by Prof. Ola Rolfson, from the University of Gothenburg.
It is often said that PROMs (Patient Reported Outcome Measures) offer valuable information to improve the quality of care. The CORE-MD Consortium has undertaken a research to evaluate the potential utility of PROMs in the clinical evaluation and investigation process as well as in the post-market surveillance phase. Professor Ola Rolfson and Professor John Chaplin from Gothenburg University have led the study and will present their findings and recommendations during this webinar.
Learning objectives :
- To receive updates on CORE-MD studies on PROMs in the evaluation of medical devices.
- To discuss the regulatory utility of PROMs.
The presentation of Prof. John Chaplin, is available here.
The presentation of Mrs. Yasemin Zeisl, is available here.
The presentation of Prof. Philip Moons, is available here.
Monitoring Life Cycle of an implant in Real Life
The CORE-MD consortium organised its eleventh webinar on “Monitoring Life Cycle of an implant in Real Life” moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.
Registries are providing significant amount of information on medical devices, especially in Orthopaedics. Within the CORE-MD Consortium research has been undertaken to explore the possible benefit of registry-based data as real-world evidence for the postmarket surveillance of medical devices.
The webinar will notably capitalise on the work done by Perla Marang Van de Mheen from Delft University and provide insights on the use of registry data for regulatory purposes. Together with colleagues from regulators, healthcare professionals and notified bodies, they will discuss how to use registries as evidence for the evaluation of medical devices.
Learning objectives :
- Discover the activities performed during the CORE-MD project analysing validity of registry data for regulatory purposes
- Understand regulators needs in post-market surveillance and vigilance
- Receive viewpoints from practising physicians and notified bodies on the possible use of registries for regulatory purposes.
Early clinical investigations of new high-risk medical devices – how lack of transparency inhibits improvement in evaluation
The CORE-MD consortium organised its tenth webinar on “Early clinical investigations of new high-risk medical devices – how lack of transparency inhibits improvement in evaluation” moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.
Learning Objectives:
- To understand the challenges of early clinical investigation in the context of the medical device regulation.
- To receive viewpoints and perspectives from Patients, Manufacturers and Regulators.
- To explore possible solutions stemming from CORE-MD recommendation.
The presentation of Prof. Peter McCulloch is available here.
The presentation of Prof. Mark Slack is available here.
The presentation of Ms Claudia Louati is available here.
Providing high-risk medical devices for children – problems and proposals
The CORE-MD consortium organised its ninth webinar on “Providing high-risk medical devices for children – problems and proposals” moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.
Learning Objectives:
- To understand the challenges of availabilities of medical devices for children
- To receive recommendation from CORE-MD on how to improve availability of medical devices for children
- To receive other regulator’s views on approval of medical devices for children.
The presentation of Kathrin Guerlich is available here.
The presentation of Em. Prof. Mark Gewillig is available here.
The presentation of Prof Berthold Koletzko is available here.
IT tools for regulatory science: aggregating available data for assisting Expert Panels and improving post-market surveillance
The CORE-MD consortium organised its eighth webinar on “IT tools for regulatory science” moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.
Learning Objectives:
- To discover the activities performed during the CORE-MD project in support to automated data
aggregation of safety notices for post-market surveillance. - To understand EMA Expert Panel’s roles in post-market surveillance and vigilance.
- To receive regulator’s perspective on the use of real-world evidence.
The presentation of Prof. Enrico Caiani is available here.
The presentation of Dr. Miguel Antunes is available here.
The presentation of Sanjeev Yoganathan is available here.
Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Whom?”
The CORE-MD consortium organised its seventh webinar on Pivotal Clinical Investigations of High-Risk Medical Devices moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.
Learning Objectives:
- To become familiar with the existing recommendations on Trial Designs of pivotal clinical investigation for medical devices.
- To explore notified bodies’ needs and expectations, in the context of the implementation of the MDR.
- To understand the role of EU regulators with respect to clinical investigations in the EU.
- To interact with key players in the field of clinical evaluation of high-risk medical devices.
The presentation of Dr. Petra Schnell-Inderst is available here.
The presentation of Richard Holborow is available here.
The presentation of Gearóid McGauran is available here.
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
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:
- Quality and transparency of clinical evidence for high-risk cardiovascular medical devices.
- Quality and transparency of clinical evidence for high-risk diabetic medical devices.
The presentation of PD Dr. Georgios Siontis is available here.
The presentation of PD Dr. Arjola Bano is available here.
The clinical evaluation of Artificial Intelligence and standalone software: keeping the balance between benefit and risk
The CORE-MD consortium organised its fifth webinar on Artificial Intelligence moderated by Em. Prof. Frank Rademarkers, CORE-MD Task leader.
Learning objectives of the webinar are:
Understand the regulatory aspects of AI in the healthcare setting.
Receive the recommendation on clinical evaluation of AI from CORE-MD
Explore current challenges in AI in a medical discipline.
Understand Ethical aspects of AI in a healthcare setting.
The presentation of Prof. Frank Rademakers is available here.
The presentation of Dr. Eva Van Steijvoort is available here.
The presentation of Dr.Claudius B Griesinger is available here.
Training and Education for Regulators, Notified Bodies, and Clinicians
On Monday 10th of July 2023, the CORE-MD consortium organised its forth webinar on training and education.
Moderated by Claudia Wild from AIHTA, the learning objectives of the webinar are:
- To present the results of the survey on perceptions of regulators, notified bodies and clinicians on Education and Training needs – performed by the CORE-MD partners.
- To reflect the perceived needs and to look into existing and future European and US-American initiatives to improve Training and Education of Regulators, Notified Bodies and Clinicians.
The presentation of Claudia Wild and Sabine Ettinger from AIHTA is available here
The presentation of Tom Melvin from Trinity College Dublin is available here
The presentation of Kenneth J. Cavanaugh and Stephanie Shedd from FDA is available here
The presentation of Esther Martinez from European Medicines Agency is available here
The presentation of Elizabeth Macintyre from Biomed Alliance is available here
Objective Performance criteria for medical devices – origins, methods, and clinical utility
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 of objective performance criteria. In his introductory words, Prof. Steyerberg outlined the longstanding experience of Prof. Krunkemeier with respect to OPCs.
Prof. Gary Grunkemeier from the Oregon Health and Science University (USA) presented the origins of objective performance criteria in cardiac devices.
Prof. Robert Byrne, from the Dublin Hospital and Royal College of Surgeons of Ireland, presented the evaluation of coronary stents.
The Origins and Objectives of European Regulations for Medical Devices
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 role of clinicians from the European Commission’s perspective.
Orthopaedic Implants and European Medical Device Regulations
Podcast
Alan Fraser & Per Kjaersgaard-Andersen – How do surgeons choose which Medical Device to implant?
Alan Fraser & Berthold Koletzko – Providing Medical Devices for children
Alan Fraser & Perla Marang-van de Mheen – Real-world evidence on the performance of High-Risk Medical Devices
Alan Fraser & Richard Holborow – Understanding how EU Notified Bodies work
New Medical Device Regulation
Core-MD videos
Improving methods for the clinical investigation and evalua
Alan Fraser (ESC), Tom Melvin (Trinity College Dublin) and Elin Karlberg (Swedish Medical Products Agency) explained the rationale underpinning the project as well as its challenges and expectations with regard to the implementation of the Medical Device Regulation. It was released on June 2023
Clinical evidence in the evaluation of high-risk medical devices
Per Kjaersgaard-Andersen (EFORT), Robert Byrne (RCSI) and Rob Nelissen (LUMC/EFORT) presented the work undertaken by CORE-MD partners to strengthen clinical evidence for high-risk medical devices (HRMD). The partners surveyed the landscape of studies available for HRMD that already received CE marking. Key findings indicate that the majority of trials are non-randomized trials, and the size of the studies were quite small with a short duration of follow-up.
Artifical Intelligence in Health: recommendation for clinical evaluation
Frank Rademakers (KU Leuven), Elisabetta Biasin (KU Leuven) and Leo Hovestadt (Elekta) highlighted the specific promises and challenges that the use and evaluation of AI-enabled medical devices pose to the modern healthcare and regulatory systems.
Core-MD on stage
Core-MD at the ESC Congress 2023
In the framework of the ESC Amsterdam Congress on 25-28 August 2023, Prof. Alan Fraser held a special Session “Clinical evidence for high-risk devices”, engaged in an insightful discussion with Stephen Windecker and Perla Marang-van de Mheen who shared the early results of the tasks they lead within which we have been reviewing the available clinical evidence on high-risk #medicaldevices in the fields of #cardiology, #orthopaedics and #diabetes as well as the quality and utility of registries for MD safety and performance assessment
Core-MD at the ESC Congress 2022
CORE-MD discussed at the European Society of Cardiology Congress in Barcelona in August 2022 with Prof Stefan James (UCR-Uppsala Clinical Research center), Prof Stefan James (UCR-Uppsala Clinical Research center) and Dr Piotr Szymanski (European Society of Cardiology)
