USA – FDA updates physiologic closed-loop control final guidance with industry feedback
The US Food and Drug Administration (FDA) has finalized guidance on physiologic closed-loop control (PCLC) technologies that includes several updates requested by medical device...
USA – Action needed on FDA regulation of AI-based medical devices
After lagging other sectors for years, the era of artificial intelligence (AI) in healthcare is dawning as its use is becoming more prevalent in a variety...
France – Une approche des études PMCF alliant IA et données de vie réelle
Le nouveau règlement européen sur les dispositifs médicaux se traduit notamment par une augmentation substantielle des exigences pour la surveillance post-commercialisation, en particulier pour...
UK – Medical devices: UK approved bodies
UK approved bodies for medical devices...
Europe – Nouvel Organisme Notifié au titre du règlement (UE)2017/746
Nouvel Organisme Notifié au titre du règlement (UE)2017/746 :
National Standards Authority of Ireland (NSAI)...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
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...
USA – Industry seeks clarity, ICH Q9 alignment in FDA’s device production software...
Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with...
Europe – Cyber Security
The increasing number of connected medical devices and ongoing digitisation in healthcare
brings new market opportunities for the manufacturer and, more importantly, improvements in patient...
