Publications : Homologation

MedTech Europe response to the open public consultation on the Proposal for an Artificial Intelligence Act (COM/2021/206)MedTech Europe response to the open public consultation on the Proposal for an Artificial Intelligence Act (COM/2021/206)MedTech Europe is a...

Joint statement in support of the New Legislative Framework and the AI ActJoint statement in support of the New Legislative Framework and the AI ActThe joint statement in favor of the new legislative framework and the AI law is a joint statement signed by a group of...

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) has...

COCIR Artificial Intelligence in EU Medical Device LegislationCOCIR Artificial Intelligence in EU Medical Device LegislationCOCIR 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...

GDPRGDPRThe 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...

Public Health Code - Bioethics lawPublic Health Code - Bioethics lawThe 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 framework for...

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 non-contractual...

New rules for Artificial Intelligence – Questions and AnswersNew rules for Artificial IntelligenceThe 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 European...

Proposed Regulation on Artificial IntelligenceArtificial Intelligence RegulationThe publication in April 2021 of the European Commission’s proposal for a European regulation on artificial intelligence is part of a global desire by all stakeholders to define the...