Medical devices: the shift from embedded to connected

International – Survey shows solid medical device industry performance despite pandemic impact

Medical device and IVD manufacturers report healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the...
Examining US FDA criteria for medical device cybersecurity and risk management

USA – FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help...

“Artificial intelligence has the potential to transform health care to better assist health care providers and improve patient care. When AI is combined with...

Europe – MDCG 2021-4 Application of transitional provisions for certification of class D in...

According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic...

USA – How to reduce bias, improve fairness in medical devices

Lessons learned in the artificial intelligence community about addressing bias could also be applied to medical devices, according to a recent perspective in the...
FDA updates safety recommendations on biotin interference in lab tests

USA – US FDA Emergency Use Authorization (EUA) routes for medical devices: Updated overview

The US Food and Drug Administration (FDA) has 26 active guidance documents related to special recommendations for medical devices during the COVID-19-associated public health...
HAS - Webinaire sur l'évaluation des dispositifs médicaux : visionnez le replay

France – Évaluation des évolutions incrémentales des dispositifs médicaux par la CNEDiMTS – Note...

Le secteur des dispositifs médicaux (DM) est marqué par un fort dynamisme. Dans les dossiers qui lui sont soumis pour évaluation, la CNEDiMTS doit...

USA – US FDA outlines next steps following COVID-19 Pandemic Recovery and Preparedness Plan...

The US Food and Drug Administration (FDA) plans to pursue five areas for near-term focus and implementation in terms of improving the agency’s responsiveness...

Europe – Evaluation renforcée des DM par des panels d’experts: la CE donne le...

Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) are aimed at ensuring that safe and performant medical...

China – NMPA publishes guidelines for Device Master File (DMF) submissions

China’s National Medical Products Administration (NMPA) has published Announcement No. 36 of 2021 (link in Chinese), which outlines the requirements for the voluntary record filing of...

Europe – Eurofins Expert Services Oy est le 20ème ON

Eurofins Expert Services Oy est le 20ème ON au titre du RDM.

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