France – Un point sur le remboursement des DM de télésurveillance
La télésurveillance médicale, qui permet à un professionnel de santé d'interpréter à distance les données pour le suivi médical d'un patient, était jusqu'ici régie...
Europe – La prolongation de la période de transition pour les dispositifs médicaux et...
L’amendement qui modifie les Règlements (UE) 2017/745 et (UE) 2017/746 en ce qui concerne les dispositions transitoires relatives à certains dispositifs médicaux (DM) et...
USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
Europe – MDCG 2024-10 Clinical evaluation of orphan medical devices
The level of clinical evidence that is required to place medical devices on the market has been increased by the MDR, including an increased...
Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation...
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The...
USA – FDA acknowledges shortcomings of Pre-Cert pilot in report
The US Food and Drug Administration (FDA) said it needs additional Congressional authority to move forward with its digital health precertification (Pre-Cert) program. While...
UK – Implementation of the future regulation of medical devices and extension of standstill...
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
International – Medical devices 2030 : Making a power play to avoid the commodity...
The days of simply manufacturing a device, and selling it to healthcare providers via distributors, have long vanished. Value is the new byword for...
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...
Europe – 38ème organisme notifié au titre du Règlement 2017/745
38ème organisme notifié au titre du Règlement 2017/745
