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...
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...
Europe – The Commission publishes guidelines on AI system definition to facilitate the first...
The guidelines on the AI system definition explain the practical application of the legal concept, as anchored in the AI Act.
By issuing guidelines on...
UK – Decision tree for navigating nanotechnology-based products for medical application
The decision tree above is to help support researchers and developers to understand how different guidelines from the International Council for Harmonisation of Technical...
Switzerland – Update of the position paper of Swissmedic and swissethics on decentralised clinical...
This position paper reflects the current state of thinking of swissethics and Swissmedic on
decentralised clinical trials (DCTs) with medicinal products in Switzerland interpreting their
respective...
Europe – Règlement (UE) 2025/40 du Parlement européen et du Conseil du 19 décembre...
Les produits doivent être correctement emballés afin d’être protégés et faciles à transporter depuis le lieu où ils sont produits jusqu’au lieu où ils...
Switzerland – Swissmedic assessment of post-market surveillance documentation
Manufacturers need to monitor their medical devices on the market because some trends may become visible only after market launch, when a device is...
