France – Télésurveillance médicale : 2 décrets actent l’intégration de la télésurveillance médicale dans...
Publiés le 31 décembre au journal officiel, 2 décrets permettent l’entrée en vigueur d’un modèle de droit commun spécifique à la télésurveillance prévu par...
Europe – MDCG 2023-2 List of standard fees
Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish...
USA – FDA official says pandemic reauthorization bill could drive VALID across finish line
A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro...
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...
Europe – MDR transition delay needs clarification, industry engagement to succeed
Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the...
UK – Artificial pancreas technology set to change lives
Individuals who are typically unable to manage their type 1 diabetes will be offered new technology to help them control their condition. Furthermore, the...
Europe – Santé publique: plus de temps pour certifier les dispositifs médicaux afin de...
La Commission a adopté aujourd'hui une proposition visant à accorder plus de temps certifier les dispositifs médicaux afin de limiter le risque de pénuries. La...
USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...
USA – FDA classifies slew of class II devices following de novo procedures
Since the last week of 2022, the US Food and Drug Administration (FDA) announced it was classifying nine products as class II devices with...
France – Ensinger Machining utilise hyperMILL pour usiner le cœur artificiel Carmat
Basée à Beynost dans l'Ain, Ensinger Machining (anciennement UMP) est spécialisé dans l'usinage de matières plastiques hautes performances. Filiale française du groupe allemand Ensinger,...
