September 7, 2020
The UK government has released a proposed regime on the regulation of medical devices in Great Britain, Northern Ireland and the European Union post Brexit.
Under the guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognise CE marks and certificates issued by European Economic Area-based Notified Bodies until 30 June 2023.
From 1 July, companies will...
October 9, 2019
British artificial intelligence (AI) firm Sensyne Health has entered a formal research agreement with the UK Medicines and Healthcare products Regulatory Agency (MHRA) to help develop methods to validate software algorithms used in digital health.
The firm announced the collaboration in its annual report for the year ending April 2019, which was published this week.
Sensyne also revealed it has...
December 2, 2014
Google-backed 23andMe is finally relaunching its mail-order personal genome service -- just not in the United States. Instead, the company is launching in England, which has a different regulatory framework than the United States.
"These products are considered to be in the lowest risk category and so there is no requirement for any premarket assessment," a spokesperson for the Medications and...
September 1, 2010
Is wireless health regulation just as grey in the UK and other parts of Europe as it is in the US?
"It's much easier to develop technology than it is to get permission to use it," Peter Bentley, the inventor of an iPhone app that supposedly turns the device into a stethoscope, told the UK's Guardian in a recent interview. Bentley, a researcher at the University College London, believes that...