The in-transition MHRA is pressing ahead with its international devices remit while progress on the UK devices regulation is awaited.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has made clear its ambitions for a global role in medical devices regulation, since the UK left the EU and the regulator was given the option of setting its own legislation.
In May, the MHRA was accepted as a full member of the International Medical Device Regulatory Forum (IMDRF), where it had acquired observer status soon after the Brexit transition period...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.
Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.
