International – IMDRF guidance aims to harmonize, streamline review reports
The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory reporting requirements across jurisdictions. The document lays out expectations not...
USA – New rule directs mammography facilities to tell patients about breast density
The US Food and Drug Administration (FDA) has issued a final rule intended to ensure patients are better informed about their breast tissue density...
Europe – Advisory group urges UK to ‘rapidly explore’ recognition of US device approvals
A group formed to advise the UK government on the regulation of medical devices is pushing for officials to “rapidly explore” building an equivalence...
France – Radiation de 2 DM essentiels dans la prise en charge de l’AVC...
Au 1er mars 2023, deux catégories de dispositifs médicaux innovants seront radiées du Titre V de la LPPR* les cathéters de thrombo-aspiration (AVC) et les guides...
Europe – Council votes unanimously to extend MDR deadlines
The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR) and to...
Europe – European Regulators Move to Increase Notified Body Capacity
The European Commission (EC) has taken new measures to relieve some of the pressure on Notified Bodies and free up capacity to perform medical...
France – Arrêté du 22 février 2023 portant approbation du référentiel d’interopérabilité et de...
Le ministre de la santé et de la prévention,
Vu le règlement (UE) 2016/679 du Parlement européen et du Conseil du 27 avril 2016 relatif...
USA – We keep trying to make AI therapists. It’s not working.
We keep failing at making an artificial-intelligence Sigmund Freud, and there is both value and risk in leaning on technology to improve our mental...
Switzerland – Dealing with certification gaps (MDCG 2022-18)
Medical devices can only be placed on the market if the manufacturer has carried out the necessary conformity assessment procedure. For medical devices in...
USA – FDA final rule reduces radiological devices reporting requirements
The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays....
