Once Medical devices reach the market, manufacturers need to provide information whenever incidents occur. Regulators receiving these informaton publish safety notices available online.
The CORE-MD consortium has developed a tool that aggregates all this data. Prof. Caiani from Politecnico Di Milano, Prof. Rob Nelissen from EFORT and Leiden, Mr. Miguel Antunes from EMA and Mr Sanjeev Yoganathan from Danish Medicines Agency discussed the relevance of such tool in the postmarket surveillance phase and in the context of the implementation of the medical device regulation. Dr Paul Piscoi provided an overview of the regulatory framework and the potential benefit of CORE-MD's outputs.
The discussion was moderated by Prof. Alan Fraser from the European Society of Cardiology.

свернуть