Europe – Machine Learning-enabled Medical Devices: Key Terms and Definitions
Artificial Intelligence (AI) is a branch of computer science, statistics, and engineering
that uses algorithms or models to perform tasks and exhibit behaviors such as...
Europe – Artificial intelligence in healthcare
In recent years, the use of artificial intelligence (AI) in medicine and healthcare has been praised for the great promise it offers, but has...
France – La HAS expérimente l’évaluation médico-économique des dispositifs médicaux numériques
Dans le cadre d'une procédure d'inscription ou de renouvellement d'inscription d’un dispositif médical sur la liste visée à l’article L. 165-1 du code de...
USA – Patient preference information: Researchers offer insights on medical device clinical trial design
The US Food and Drug Administration (FDA) has increasingly called for the inclusion of patient preference information (PPI) to inform its regulatory decision-making for...
Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex...
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...
France – La Société française de dermatologie appelle les autorités à réglementer l’usage de...
PARIS (TICpharma) - La Société française de dermatologie (SFD) et son groupe de télédermatologie et e-santé (Teldes) a appelé les autorités de santé à...
Europe – Manual on borderline and classification for medical devices under Regulation (EU) 2017/745...
Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of...
Europe – 37 ème organisme notifié au titre du Règlement 2017/745
37 ème organisme notifié au titre du Règlement 2017/745
USA – EPA proposes rules on EtO with implications for medical device sterilization
The US Environmental Protection Agency (EPA) has proposed two much-anticipated rules that would restrict how much ethylene oxide (also referred to as EO or...
Europe – MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products :...
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related...
