Theme In house devices Target Audience Health institutions, healthcare professionals Products concerned MD, IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2020-16MDCG 2021-24 This MDCG document addresses so-called "in house"...
Theme PSUR – Article 86 MDR Target Audience Manufacturers of class IIa, IIb, and III medical devices Products concerned MD Regulatory reference MDR (EU) 2017/745 Documents mentioned MDCG 2022-14MDCG 2021-25MDCG 2021-3MDCG 2021-1 rev.1IMDRF Adverse Event Terminology...
Expert biologist in the field of health. Holder of a Marie-Curie H2020 research doctorate in Health and Development Biology. This interdisciplinary project focused on identifying the effects of nanomaterials and organic pollutants on the reproductive toxicity of...
Area Publication or last update date Text Theme Scope nexialist synthesis EU 2016 Regulation (EU) 2016/679 on General Data Protective Regulation Data management Artificial intelligence Link EU 2018 European Commission : Questions and Answers: coordinated plan...
Government of the Netherlands: Legal analysis – European legislative proposal draft AI act and MDR/IVDRGovernment of the Netherlands: Legal analysis – European legislative proposal draft AI act and MDR/IVDRThis legal analysis carried out by Hooghiemstra & Partners...
WHO Ethics and Governance of AI SystemsWHO Ethics and Governance of AI SystemsThe World Health Organization released a general report in 2021 on the use of artificial intelligence in health and the challenges and risks that these technologies can produce. In this...
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...
