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Canada – Draft guidance on managing applications for medical device ...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...
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...
Europe- MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies
Guidance documents are by definition not compulsory. However, all guidance
documents endorsed by the MDCG reflect the interpretation of the EU law jointly
agreed by the...
