Europe – Pilot on the Advice from the Expert Panels to Manufacturers of HighRisk...
Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation, MDR) Article 106 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (In Vitro...
France – Mesure de glycémie sans piqûre : l’ANSM et la DGCCRF alertent sur...
Le diabète, est une maladie chronique caractérisée par une dérégulation du taux de sucre dans le sang (glycémie) et qui demande un suivi régulier...
Europe – EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH)...
EMA’s human medicines committee (CHMP) has issued the first Qualification Opinion (QO) on an innovative development methodology based on artificial intelligence (AI). The tool,...
Europe – Update – MDCG 2020-16 rev.4 – Guidance on Classification Rules for in...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
Europe – EU device expert warns manufacturers not to wait until the last minute...
AN EU medical device expert advised manufacturers to avoid submitting applications at the last minute for approval under the Medical Devices Regulation (MDR) and the In Vitro...
Europe – Clinical strategy as part of pre-submission dialogue between manufacturer and Notified Body
MedTech Europe, AESGP, MedTech &Pharma Platform and COCIR would like to express their concern that the recently updated MDCG 2019-6: Requirements relating to notified...
Australia – Consultation: Proposed changes to IVD medical device classifications and definitions
In-vitro diagnostic (IVD) medical devices are regulated in Australia by the Therapeutic Goods Administration (TGA) having regard to the risks (to the individual or...
Europe – Urgent call for clarity on clinical strategy discussions
MedTech Europe, AESGP, MedTech & Pharma Platform and COCIR would like to express their concerns that the recently updated MDCG 2019-6: Requirements relating to notified bodies...
France – Un pas de plus dans la lutte contre l’endométriose : lancement du...
L’endométriose : une maladie chronique invalidante
L’endométriose est une maladie gynécologique chronique qui touche entre 1,5 et 2,5 millions de femmes en France. Elle se caractérise par la...
Canada – Draft guidance on managing applications for medical device ...
Medical devices are classified into 1 of 4 classes, where Class I represents the lowest risk and Class IV represents the highest risk. Under...
