Europe – MDCG 2022-11 MDCG Position Paper Notice to manufacturers to ensure timely compliance...
With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the
regulatory framework for medical devices and in vitro diagnostic medical devices
(IVD) has changed...
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....
UK – Artificial pancreas technology set to change lives
Individuals who are typically unable to manage their type 1 diabetes will be offered new technology to help them control their condition. Furthermore, the...
Europe – Convergence: MDR timeline extension is smoothing transition, but concerns persist
The European Union’s Medical Device Regulation (MDR) timeline extension has addressed some of the issues manufacturers raised with the transition period but the process...
Europe – IVDR: Commission adds risk management standard to harmonized standards list
The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro...
Europe – Notified bodies have yet to issue MDR certificates for 85% of legacy...
Notified bodies have yet to issue Medical Device Regulation certificates for more than 85% of the products previously certified under the old directives,...
Europe – Accord avec le Royaume-Uni relatif à la reconnaissance mutuelle en matière d’évaluation...
Depuis le retrait du Royaume-Uni de l’UE, l’accord entre la Suisse et l’UE relatif à la reconnaissance mutuelle en matière d’évaluation de la conformité...
Europe – Nouvel Organisme Notifié au titre du règlement (UE)2017/746
Nouvel Organisme Notifié au titre du règlement (UE)2017/746 :
MDC MEDICAL DEVICE CERTIFICATION GMBH...
Europe – MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical...
This Q&A intends to clarify certain interfaces between the Regulation (EU) No 536/2014 on
clinical trials for medicinal products for human use (CTR) and Regulation...
Spain – Des applis mobiles pour prédire le risque d’exacerbations de BPCO et détecter...
BARCELONE (TICpharma) - Des applications mobiles utilisant l'intelligence artificielle (IA) apparaissent comme des outils d'aide à la prédiction des exacerbations de bronchopneumopathie obstructive chronique...
