On 24 November 2023, the Biomedical Alliance held its General Assembly gathering representatives from their 36 member scientific societies.
In the framework of this meeting, a dedicated session, chaired by Prof. Elisabeth Mcintyre, Biomedical Alliance President elect, on real-world evidence and registries was organised to present the challenges of the implementation of the Medical Device Regulation.
Prof. Alan Fraser, CORE-MD Coordinator, presented an overview of the work done in CORE-MD referring notably to the various publications detailing the potential benefit of registries to post-market surveillance.
Dr Paul Piscoi from the European Commission as well as Donal O’Connor from Health Product Regulatory Agency, Ireland, presented the regulatory perspective of the implementation of Medical Device Regulation.
Kelly Plueschke from EMA referred to the EMA guidelines on registry based studies focusing on ongoing work to further enhance the use of registry data.
Prof. Anne Lübbeke-Wolff from EFORT, reported on the studies undertaken as part of CORE-MD task and highlighted the variety and heterogeneity of registries but their potential utility to contribute to the implementation of the regulation.
