Europe – COMMISSION IMPLEMENTING REGULATION (EU) …/… laying down common specifications for the groups...
This Regulation lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745.
Annex...
USA – FDA proposes breakthrough status for devices that address health disparities
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in...
USA – FDA issues roadmap to medical device regulatory guidance topics list for 2023
The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center...
USA – FDA launches TAP Pilot to speed access to safe and innovative medical...
The US Food and Drug Administration announced that it has launched a pilot program designed to foster earlier conversations in the medical device product...
Europe – IA: la Commission européenne renforce l’exigence de garantie humaine
PARIS (TICpharma) - Le futur règlement européen sur l'intelligence artificielle (IA) devrait être finalisé "début 2023", signant le "top chrono" pour la mise en...
Europe – 34ème Organisme Notifié
ENTE CERTIFICAZIONE MACCHINE SRL
Via Ca’ Bella, 243/A - loc. Castello di Serravalle
40053 Valsamoggia (BO)
Country : Italy
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...
USA – FDA device center guidance priority lists targets COVID, digital health
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the...
France – Concevoir un dispositif médical conformément à l’ISO 13485:2016
Avant sa mise sur le marché, un dispositif médical passe par de multiples phases de conception. Les premières étapes, dites de faisabilité, consistent à...
UK – Guidance : Software and AI as a Medical Device Change Programme
Software (and AI in particular) plays an increasingly prominent role in health systems, having a wide set of applications across health and social care....
