EU Publishes Regulation (EU) 2026/1744: The Digital Omnibus on Artificial Intelligence
European Union publishes Regulation (EU) 2026/1744 (Digital Omnibus on AI), amending the EU AI Act to streamline compliance, adjust timelines, and relieve SMEs.
European Commission Publishes Consolidated Version of the AI Act Incorporating Digital Omnibus Amendments
The European Commission has published an unofficial consolidated version of the AI Act incorporating the Digital Omnibus amendments, providing an updated reference for manufacturers and other stakeholders.
MedTech Europe Calls for Greater Alignment in EU Digital Omnibus Proposals
MedTech Europe highlights key challenges in the Digital Omnibus, including AI Act timelines, GDPR updates, and Data Act implications for manufacturers.
Notified Bodies apelam à Comissão Europeia por um quadro mais eficiente e harmonizado no contexto do AI Act
A Team NB e o NBCG-Med apresentaram à Comissão Europeia um contributo que sublinha a importância de simplificar e harmonizar o processo de avaliação de conformidade no contexto do AI Act e dos regulamentos MDR/IVDR. O documento alerta para o risco de escassez de Organismos Notificados especializados, o aumento dos custos de conformidade e o impacto sobre as PME do setor médico.