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...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

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...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

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,...
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) - updated information

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...
SCCS - Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)

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...
DEKRA accredited under the MDR

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...

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