UK – MHRA and NICE awarded £1.8m to explore regulation of digital mental health...
The healthcare sector has seen a considerable increase in the number of digital mental health tools made available in recent years. Despite this improvement...
Europe – Cyber Security
The increasing number of connected medical devices and ongoing digitisation in healthcare
brings new market opportunities for the manufacturer and, more importantly, improvements in patient...
Europe – Data generated from ‘Off-Label’ Use of a device under the EU Medical...
‘Off label use’ is mentioned within the Medical Device Regulation (MDR) in Annex XIV Part B, in the context that manufacturers should proactively identify...
Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex...
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...
Europe – « Le risque d’une pénurie de dispositifs médicaux fait craindre une nouvelle...
Alors que la crise du Covid-19 n’est toujours pas terminée, gardons à l’esprit la première leçon qu’elle nous a apprise : l’anticipation est la clé...
Europe – Notified bodies’ paper on the application of hybrid audits to quality management...
Team-NB would like to emphasise that we do not regard this document as final rule or guidance, but rather as our view/expectation for the...
UK – MHRA appoints first new UK Approved Body to certify medical devices since...
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies,...
UK – UK regulator MHRA to raise medical device registration and other fees by...
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has published a consultation for industry comment regarding a proposed increase in fees the agency...
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 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions...
Article 110(2) and 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) state that devices which are covered by valid certificates...
