CORE-MD Final Conference: Results, Research, Recommendation on high-risk Medical Devices

In the introductory purposes, Prof. Alan Fraser from the ESC reminded the audience the history of the adoption of the MDR and the challenges that it aimed to address. He also reviewed the CORE-MD objectives and its expected impact on the implementation of the MDR.

The first session addressed the issue of the European Regulatory system for medical devices. Chaired by Prof. Franz Weidinger from ESC and Ass. Prof. Per Kjærsgaard-Andersen from EFORT, this session offered various viewpoints on the regulatory system. Rainer Becker, Director of the Medical Products and Innovation at the European Commission made an update on the implementation of the Medical Device Regulation. He recalled the objectives of the Regulation which were to improve the safety of medical devices placed on the market and increase the level of evidence required from manufacturers. On behalf of the Belgian Presidency of the EU, Paul Balecher pointed to the need to strengthen cooperation on medical devices to foster innovation while ensuring that safe products are placed on the market.

Session 1 https://youtu.be/6UHMog-aOXg

The second session presented the main results of the CORE-MD projects after three years of intense activity. Chaired by Dr Paul Piscoi from the European Commission and Prof. Anne Lübbeke from the Geneva university Hospital.

In his presentation, Prof. Robert Byrne highlighted work done in Work Package 1 on the quality and transparency of evidence for implantable cardiovascular medical devices. He also pointed to a specific study conducted on age, sex, ethnicity in prospective studies of high-risk medical devices.

Prof. Perla Marang-van de Mheen from the Delft University presented the outcome of the research made on the use of registry data for postmarket surveillance. Given the challenge of such use by regulators and the variety of types of real world data (electronic health records, registries, safety notices, …), the reliability and the relevance of data was key to secure concrete use by decision-makers. The outcome of the research showed that real-world data are heterogeneous. The decision framework established by the partners involved aimed at helping the assessment of medical device performance. She also presented the complementary study performed with Prof. Caiani from Politecnico Di Milan on the comparison of data provided by safety notices and registries.

Prof. Frank Rademakers reported on the recommendation on the clinical evaluation of Artificial Intelligence medical devices. Following a risk-based approach, the recommendation provides a score based on technical performance, clinical performance and valid clinical association. It proposed a simple scoring system to help regulators to define what needs to be done in pre-release and post-release phase of an AI-based medical devices.

Prof. Berthold Koletzko from the European Academy of Paediatrics emphasized the results of the scoping review performed by his team pertaining to clinical trials on medical devices. He notably reminded the audience about the recommendation on clinical investigations and evaluation of high risk medical devices for children drafted by the partners further to the Munich Workshop.

Session 2 part 1 https://youtu.be/a4h8HZVEWP4

Session 2 part 2 https://youtu.be/a4h8HZVEWP4

Prof. Rob Nelissen from Leiden University and EFORT, and Prof. Rita Redbarg from university of California co-chaired the third session on science-based regulatory policy for medical devices.

Prof. Alan Fraser from ESC presented the main recommendation deriving from the CORE-MD partners’ work. He pointed to the roadmap on education and training, the recommendation for patients involvements in PROMs, the risk score to guide requirements for the clinical evaluation of AI or the Ethics Charter. All these recommendations are available on core-md website.

Miguel Antunes from the European Medicines Agency shed light on the role of EMA in regulatory science in Human medicine. He presented the Agency’s research needs with the different committees established and how these were supporting and enabling further research following a continuous, collaborative, comprehensive and consolidated process.

Penilla Gunther from the European Patient Safety Foundation highlighted the consequences of failed implementation on patient safety. She also provided insights on how to avoid failed implementation.

Sabina Hoekstra from NBCG-Med  shared the notified bodies perspective on the implementation of the medical devices regulation. She recalled the role of notified bodies as defined by the MDR and their subsequent tasks and responsibilities in the assessment of medical devices. She insisted on the fact that the MDR had significantly increased the expectations of the patients and regulators to have safe and secure medical devices on the market. Notified Bodies had had to adapt to this regulation and significantly increased its workforce both quantitatively and qualitatively.

Session 3 : https://youtu.be/uzlruwHdbkU

During the fourth session chaired by Prof. Elisabeth Macintyre from the Biomedical Alliance and Prof. Alan Fraser from the ESC, panellists focused on the priorities to foster regulatory convergences.

Niall McAleenan, from HPRA, presented the work of the IMDRF and its link to the European Management Committees. He stressed the benefits of regulatory convergence as well as the need for further work in this regard to address the remaining gaps.

Flora Giorgio from the European Commission presented the Commission’s perspective and activities in regulatory affairs. She presented the achievements of the European institutions and Member States in working to strengthen the regulatory framework.

Petra Zoellner from MedTech Europe presented the challenges induced by the MDR. According to a survey report from summer 2023, bureaucracy, high costs and length of procedures were the main challenges of manufacturers of medical devices.

Session 4: https://youtu.be/0CC0u0wrI-Y