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 Bodies, Scientific Societies, Patients, Universities as well as experts of the project Advisory Board conveyed in Leuven to explore the project outputs.
Divided into seven sessions, the programme of this Project Board meeting enabled task leaders to present their findings and discuss it among participants.
In the framework of the first session dedicated to current regulatory practices for high-risk medical devices, the outcome of litterature review on cardiac, diabetic and paediatric devices were presented. For instance in the field of diabetic devices, more than 6000 studies were identified but, after applying search criteria, 1000 texts were fully assessed, out of which 117 studies were eligible for systematic review on efficacy and safety. The studiy design showed that 30% were Randomised Control Trials (RCT), 24% non RCT and 46% were observational. Most studies are small with short follow-up time and methodological heterogeneity. There is need for developing standards for future investigations. When comparing device types, the study undertaken showed that
– there is limited clinical studies published before CE Marking
– the level of clinical evidence varies a lot
– the published RCT represent 19% of cardiac, 9% of orthopaedic and 30% for diabetic devices studies.
– minimum requirement for trial protocol should be establised.
The second session covered generic regulatory process and focused on patient reported outcome measures (PROMs), early-phase evaluation of high-risk medical devices and medical devices for children. It was highlighted that according to the research, PROMS were seldomly used as primary outcome measure for the assessment of orthopaedic, cardiac and diabetic devices. Thechallenges for medical device in children was also presented and referred to the outcome of the Munich workshop.
In the third session, an overview of the regulatory guidance on methodologies for clinical investigation was presented. About 30 documents exists but do not cover in the same area (early phase, clinical investigation, …). Additionnally, the recommendation on clinical evaluation of artificial intelligence medical devices were also presented and discussed.
Within session four, experts from the Advisory Board reviewed the progress and challenges of the EU Medical Device Regulation. The US perspective on accelerated approvals and breakthrough designation was also presented as well as the exploitation of registry-based real-world data.
The fifth sesssion covered the issue of postmarket surveillance. Update on the tool developed on post-market surveillance was presented and showed that more functionalities and more countries have been included in the tool. The work done on quality and utility of orthopaedic and cardiovascular registries in Europe showed that there were significant differences in cardiac and orthopaedic registries in terms of completeness, coverage, etc. It appeared clearly in the research that there was large heterogeneity of registries preventing combining and joining the regulatory utility of registries.
In the framework of session six, the issue of training and education of key stakeholders was presented. The preliminary work on the elaboration of an Ethic Charter were also discussed by the participants to provide relevant recommandation without duplicating existing recommendation.
The seventh session focused on the hierarchy of methodologies for clinical evaluation. Participants insisted on the need to propose a matrix rather than a hierarchy to cover each stage of the development of the devices.
The ouputs presented at the Project Board meeting will be published in Scientific papers in the coming weeks and will be made available on CORE-MD website.