UK – Extension of CE certificates
The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR). The new...
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 – 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 – Health Technology Assessment : Guidance on reporting requirements for multiplicity issues and...
This guidance describes how to deal in practice with multiplicity issues and
complementary analyses (like specific subgroup analyses, specific post hoc analyses and sensitivity analyses)...
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...
Europe – MDCG 2022-4 Rev.1 Guidance on appropriate surveillance regarding the transitional provisions under...
Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that
devices which are covered by valid certificates issued by a notified...
