EU must tackle clinical trials shortfalls as current lack of evidence is "appalling"
This article was originally published in Clinica
With devices becoming increasingly complex, Competent Authorities must ensure there are sufficiently well-trained experts at Notified Body level, particularly for assessing innovative devices and for clinical trials. But authorities are facing difficult resource issues and finding experts is a real challenge. Dr Susanne Ludgate of the UK MHRA told Amanda Maxwell where the problems lie, and what she believes to be the solutions
You may also be interested in...
Following hot on the heels of its Rapidly Manufactured Ventilator Specification document, the UK’s regulator has issued another speedy regulatory permit for fast production of respiratory assist devices.
The UK is taking measures to increase its ventilator stock from 8,000 to some 30,000, but it will take time to make them available. Many are asking whether the government really rejected EU help, which could have brought relief sooner, because of Brexit.
How to get non-CE-marked medical devices onto the UK market at speed