No âmbito da operacionalização da base de dados europeia de dispositivos médicos (EUDAMED), recordamos todos os fabricantes e produtores de sistemas e conjuntos de dispositivos médicos que a conclusão do registo na plataforma EUDAMED deve ser efetuada até 28 de...

The European Commission has introduced the AIActComplaintsTool, allowing individuals and organisations to submit a complaint to the AI Office when they believe that a provider or deployer of an AI system may have infringed the AI Act.   The AI Act Complaints Tool...

The European Commission has published Implementing Decision (EU) 2026/2479, introducing an important update to the harmonised standards supporting Regulation (EU) 2017/745 (MDR).

  This document provides guidance to manufacturers, notified bodies, expert panels, health institutions, and regulators on the clinical evidence requirements for orphan IVDs and for IVDs that have an orphan indication within the meaning of this guidance. The...