The EU Medical Device Regulation 2017/745 defines new rules for the certification and post-market surveillance of medical devices (MD), including an additional review by Expert Panels of clinical evaluation data for high-risk MD if reports and alerts suggest possibly associated increased risks.
Within the EU-funded CORE-MD project, a tool was developed to support such process in which web-accessible safety notices (SN) are automatically retrieved and aggregated. It relies on their specific MD categories and the European Medical Device Nomenclature (EMDN) classification. Applying an Entity Resolution (ER) approach it enriches data integrating different sources.
The performance of such approach was tested through a pilot study on the Italian data and published into the journal “Therapeutic Innovation & Regulatory Science”.
CORE–MD is a European Union Horizon 2020 project. It reviews methods for evaluating high-risk medical devices in order to translate expert evidence into advice for EU regulators and to recommend an appropriate balance between innovation, safety, and clinical effectiveness.
Led by the European Society of Cardiology (ESC) and the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), the consortium includes 22 partners.