Europe – Règlements européens relatifs aux dispositifs médicaux et de diagnostics in vitro :...
Le 10 juillet 2024, nous avons accueilli à Saint-Denis nos collègues européens dans le cadre d’un atelier de travail sur les dispositifs médicaux organisé...
France – Analyse des déclarations de la base nationale des évènements indésirables graves associés...
Le secteur des dispositifs médicaux (DM) est qualifié de vaste, diversifié, hétérogène : il comporte plus de 20 000 types de produits, allant des...
Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards...
About the updates
Health Canada has updated the:
List of recognized standards for medical devices and
Guidance on using standards to support compliance with the Medical...
China- Medical Device Administrative Control System (MDACS)
During the life-cycle of a medical device, changes may take place from time to
time. To safeguard public health, the information in the Medical Device...
France – Ballons gastriques Allurion : recommandations pour limiter la survenue de complications graves
Les ballons gastriques de la marque Allurion sont des dispositifs médicaux utilisés chez des patients en situation de surpoids ou d'obésité. Nous appelons à...
USA – FDA issues final guidance user fees for combination products
The US Food and Drug Administration (FDA) on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the...
USA – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
The opioid epidemic is a serious and complex public health emergency facing the United States. The Agency has already taken significant steps to decrease...
Europe – Regulation (EU) 2024/1689 of the European Parliament and of the Council of...
The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for...
USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...
Europe – Regulation (EU) 2024/1860 of the European Parliament and of the Council of...
Regulations (EU) 2017/745 (3) and (EU) 2017/746 (4) of the European Parliament and of the Council establish a regulatory framework to ensure the smooth functioning of the internal market...
