USA – FDA rules on definitions of device; issues revised form for reporting adverse...
The US FDA has issued final guidance clarifying how the agency interprets existing references to section 201(h) of the FD&C Act and how the agency intends...
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USA – FDA issues draft guidance on decentralized clinical trials
In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs,...
Brazil – Brazil’s ANVISA repeals medical device regulations related to the coronavirus pandemic
Brazilian medical device market regulator ANVISA announced the repeal of several regulations and requirements related to the COVID-19 pandemic which have been deemed no...
Europe – MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical...
This Q&A intends to clarify certain interfaces between the Regulation (EU) No 536/2014 on
clinical trials for medicinal products for human use (CTR) and Regulation...
UK – UK to strengthen regulation of medical devices to protect patients
MHRA to reform medical devices regulation to improve patient health and encourage innovation
The UK is seizing the opportunities provided by leaving the...
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....
