Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations

Software has become an increasingly important part of the medical device landscape. It is estimated that one in four medical devices either incorporate medical device...

Europe – Artificial Intelligence Act : un nouveau règlement européen à suivre de près

L’AIA est une proposition de règlement du parlement et du conseil européens dévoilée le 21 avril 2021, dont l'entrée en vigueur est programmée dans...
COVID-19 outbreak: the presidency steps up EU response by triggering full activation mode of IPCR

Europe – Medical devices: Council adopts new measures to help prevent shortages

The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to...

Europe – Santé publique: plus de temps pour certifier les dispositifs médicaux afin de...

La Commission a adopté aujourd'hui une proposition visant à accorder plus de temps certifier les dispositifs médicaux afin de limiter le risque de pénuries. La...

Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...

This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations...

Europe – European Commission Publishes Directive on the Liability of Artificial Intelligence Systems

On September 28, 2022, the European Commission published its long-promised proposal for an AI Liability Directive.  The draft Directive is intended to complement the...

Europe – Règlement d’exécution (UE) 2023/1194 de la Commission du 20 juin 2023 modifiant...

Est paru le 21 juin 2023 au Journal Officiel de l’Union Européenne le Règlement d’exécution (UE) 2023/1194 modifiant les dispositions transitoires établies dans le Règlement...

Europe – Publication of the Third Edition of the “Clinical Evidence Requirements under EU...

We are pleased to announce the publication of the Third Edition of the “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” Regulatory eBook. The Questions and Answers eBook was developed by...

Europe – Team-NB : Best Practice Guidance for the Submission of Technical Documentation under...

This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...

Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing

The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push...

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