22 Mar 2023 | Artificial intelligence
Joint statement in support of the New Legislative Framework and the AI Act Joint statement in support of the New Legislative Framework and the AI Act The joint statement in favor of the new legislative framework and the AI law is a joint statement signed by a group of...
22 Mar 2023 | Artificial intelligence
Will a NB designated under MDR/IVDR will be able to assess the conformity of a MD incorporating AI? Will a NB designated under MDR/IVDR will be able to assess the conformity of a MD incorporating AI? Team NB (European Association of Medical devices Notified Bodies)...
22 Mar 2023 | Artificial intelligence
COCIR Artificial Intelligence in EU Medical Device Legislation COCIR Artificial Intelligence in EU Medical Device Legislation COCIR published an analysis in 2020 on AI-based devices in the scope of MDR and IVDR. The purpose of this analysis is to provide an update on...
22 Mar 2023 | Artificial intelligence
GDPR GDPR The GDPR (General Data Protection Regulation 2016/679) sets limits on the use of personal data considered sensitive. It provides many opportunities for effective monitoring and enforcement of fairness, transparency, individual rights and granting individual...
22 Mar 2023 | Artificial intelligence
Public Health Code – Bioethics law Public Health Code – Bioethics law The bioethics law after several revisions was finally adopted in August 2021. In its draft format, Article 11 of this law, which became Article 17 in its final format, introduces a legal...
