Europe – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro...
In April 2017, the European Parliament and the Council adopted the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices...
Europe – Evaluation clinique : retours d’expérience d’un organisme notifié
Avec le Règlement (UE) 2017/745 sur les dispositifs médicaux (RDM), l’évaluation clinique est devenue une étape centrale dans l’évaluation de la conformité des produits,...
UK – Three new UK Approved Bodies to certify medical devices announced by the...
TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
Europe – Team-NB asks for regulatory clarity and for manufacturers to not delay MDR...
Notified bodies (NB) say that while extending the deadline to transition to EU Medical Device Regulation (MDR) has been a positive move, there is...
UK – NICE recommends AI technologies for radiotherapy treatment planning
The recommendation aims to speed up the time taken to produce outlines of healthy organs, in order to help target cancer cells while avoiding...
UK – Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the...
MHRA is aware of a very small number of cases of squamous cell carcinoma (SCC) and different types of lymphoma, found within the fibrous capsule...
Europe – MDR/IVDR survey shows NBs have increased capacity
A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In...
UK – Implementation of medical devices future regime
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
UK – Software and Artificial Intelligence (AI) as a Medical Device
Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices...
