Europe – European Commission Publishes Directive on the Liability of Artificial Intelligence Systems
On September 28, 2022, the European Commission published its long-promised proposal for an AI Liability Directive. The draft Directive is intended to complement the...
Europe – Notified bodies’ paper on the application of hybrid audits to quality management...
Team-NB would like to emphasise that we do not regard this document as final rule or guidance, but rather as our view/expectation for the...
USA – FDA revises final guidance on modifying remote monitoring devices
The US Food and Drug Administration (FDA) has updated final guidance on its enforcement policy for remote patient monitoring devices in an effort to...
France – Plusieurs défis à relever pour assurer la sécurité des DM connectés (Afib)
LILLE (TICsanté) - Pour relever le défi de la sécurité des dispositifs médicaux (DM) connectés, il faut travailler sur la formation des ingénieurs biomédicaux,...
UK – MHRA warns of unsafe counterfeit anti-choking devices
The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy counterfeit or unbranded anti-choking devices as they do not...
France – Comment la médecine in silico peut accélérer l’innovation en matière de DM
La complexité des dispositifs médicaux modernes croît avec l'amélioration de leurs fonctionnalités, qui représentent un bénéfice pour les patients, mais augmentent également les risques...
Europe – Add 1 – MDCG Position Paper on the application of Art.97 MDR...
The position paper MDCG 2022-18 was published in December 2022 to provide a
uniform approach to the application of Article 97 of Regulation (EU) 2017/745...
Europe – Commission proposes measures to improve the availability of in vitro diagnostics
Today, the European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. With this...
Europe – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of...
Medical devices can be manufactured and used within EU health institutions (in-house
devices), on a non-industrial scale, to address the specific needs of target patient...
USA – US FDA withdraws COVID-era guidance for medical device and IVD market approval...
The US Food and Drug Administration announced that it has withdrawn its temporary policies related to the COVID-19 pandemic because they are no longer...
