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.
Team NB Publishes New Good Practice Guide for the Submission of Technical Documentation under the MDR
The new version of Team NB's good practice guide for submitting technical documentation under Regulation (EU) 2017/745 (MDR) provides clear guidance for medical device manufacturers. The document addresses the structuring of dossiers, the consistency of data, common mistakes to avoid and the importance of effective communication with Notified Bodies.
Team-NB Publishes Report on MDR Technical Documentation Training
Team-NB has released a report on technical documentation training in the context of MDR 2017/745, which is essential for medical device manufacturers. The data shows that only 50% of SMEs have submitted a technical dossier, while 54% of large companies have already updated at least half of their documentation. The report highlights the need for continued support for small and medium-sized enterprises.