France – Dispositifs médicaux numériques : liste des activités de télésurveillance
Le décret n° 2022-1767 du 30 décembre 2022 décrit les modalités de prise en charge pour les dispositifs médicaux numériques (DMN) de télésurveillance inscrits sur la...
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 – 37 ème organisme notifié au titre du Règlement 2017/745
37 ème organisme notifié au titre du Règlement 2017/745
USA – Lasers: FDA publishes guidance on surveying, leveling and alignment products
The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a regulated laser...
USA – Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related...
