International – Use Errors Part 2: Estimating the severity of potential harms
In a previous blog post, I wrote about the challenge of estimating the likelihood of a use error. The main take-aways were that the estimates...
France – L’ATIH lance une nouvelle application pour étudier la consommation de médicaments et...
L’ATIH lance une nouvelle application « Médicaments et dispositifs médicaux » sur ScanSanté, pour étudier finement les données de consommation des médicaments et dispositifs médicaux (DM) dans les...
Europe – IVDR watch: IVD Expert Panel now accepting submissions for performance evaluation consultations
The European Expert Panel established to provide scientific and technical expertise regarding in vitro diagnostic (IVD) devices under the In-vitro Diagnostic Medical Devices Regulation...
Europe – European IVDR application partially postponed
The European Commission has proposed delaying compliance deadlines for the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would allow some manufacturers more...
Europe – Commission Européenne 25ème organisme notifié au Titre du Règlement (UE) 2017/745
SGS Belguim NV est le 25ème organisme notifié au Titre du Règlement (UE) 2017/745...
UK – The past, the present, and the future of clinical trials transparency in...
The UK has been leading the way in supporting and promoting transparency of clinical trials. Following our exit from the EU, the MHRA has...
France – Les dangers liés au MDR : la profession tire la sonnette d’alarme...
Entré en vigueur le 26 mai 2021, le nouveau règlement européen (UE) 2017/745 (MDR) prévoit une période de grâce de 3 ans. En d'autres...
USA – Device companies urge FDA to refine guidance on PCLC devices
Medical devices companies urged the US Food and Drug Administration (FDA) to expand the scope of its recent guidance on assessing physiologic closed-loop control...
Brazil – Brazil’s ANVISA issues registration rules for software as a medical device (SaMD)
ANVISA, Brazil’s medical device market regulator, has published new regulations targeting software as a medical device (SaMD) set to take effect in July 2022.
ANVISA’s RDC...
India – India’s DCGI adds more medical device testing laboratories
Helping to make getting your medical device or in vitro diagnostic (IVD) device testing done a little bit easier, the Drug Controller General of...
