UK – NHS rolls out artificial pancreas in world first move
Tens of thousands of children and adults living with type 1 diabetes across England are set to receive an ‘artificial pancreas’ in a world-first...
UK – Medical devices – extended acceptance of CE marked medical devices on the...
A statutory instrument has been laid in Parliament, which will enable an extended timeframe for acceptance of CE marked medical devices on the Great...
Europe – EMA to launch scientific advice pilot for high-risk devices in late February
The European Medicines Agency (EMA) will begin accepting volunteers for a pilot program to provide scientific advice to manufacturers of high-risk medical devices by...
Europe – UPDATE – MDCG 2020-3 Rev.1 – Guidance on significant changes regarding the...
Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with...
Europe – Overview of language requirements for manufacturers of medical devices
The Commission and Member States have created MDR and IVDR tables.
These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and...
Europe – Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach
Notified body (NB) capacity has risen significantly in recent years as the number of designations has increased; however, some manufacturers have yet to transition...
UK – New device launched for diagnosing prostate cancer
CamPROBE may save vital time and money while reducing the risk of infection
November will witness the launch of a new device that is set...
Europe – LNE-GMED UK désigné dans le cadre de la réglementation britannique relative aux...
En décembre 2023, LNE-GMED UK, filiale GMED du groupe LNE a été accrédité par UKAS (United Kingdom Accreditation Service) au titre de la norme...
Europe – Team-NB : Best Practice Guidance for the Submission of Technical Documentation under...
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...
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....
