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...
22 Mar 2023 | Artificial intelligence
Proposal for a directive of the European parliament and of the council on adapting non-contractual civil liability rules to articial intelligence (AI liability Directive) Proposal for a directive of the European parliament and of the council on adapting...
22 Mar 2023 | Artificial intelligence
New rules for Artificial Intelligence – Questions and Answers New rules for Artificial Intelligence The new rules for artificial intelligence are a set of guidelines developed by the European Commission to regulate the use of artificial intelligence (AI) in the...
