New guidance on medical device standalone software and apps
The Medicines and Healthcare Products Regulation Agency (MHRA) offers useful guidance on the difference between apps that are regulated as medical devices and those that are related to healthcare but do not qualify.
What’s the issue?
One of the fastest-growing areas of wearable technology is the market for wearable medical devices. Wearable medical technology is, understandably, heavily regulated at a national and European level but there is still a great deal of uncertainty about how the software in medical devices should be regulated. There is a particular issue with borderline medical devices such as fitness monitors and when or whether they should be considered to be medical devices or simply recreational tools not subject to the medical devices regulatory framework.
What’s the development?
The MHRA has issued guidance on when ‘standalone software’, defined as ‘software that has medical purpose that at the time of it being placed onto the market is not incorporated into a medical device’ and that can include apps, qualifies as a medical device…
Click on the link below to read the rest of the Taylor Wessing briefing.
Sign in or Register to continue reading this article
It's quick, easy and free!
It takes just 5 minutes to register. Answer a few simple questions and once completed you’ll have instant access.Register now
Why register to The Lawyer
In-depth, expert analysis into the stories behind the headlines from our leading team of journalists.
Identify the major players and business opportunities within a particular region through our series of free, special reports.
Receive your pick of The Lawyer's daily and weekly email newsletters, tailored by practice area, region and job function.
More relevant to you
To continue providing the best analysis, insight and news across the legal market we are collecting some information about who you are, what you do and where you work to improve The Lawyer and make it more relevant to you.
News from Taylor Wessing
News from The Lawyer
Briefings from Taylor Wessing
For the tax year from 6 April 2014, the standard lifetime allowance has reduced from £1.5m to £1.25m.
One of the areas highlighted last year by the Regulator was the regulation of workplace DC pension schemes.
Analysis from The Lawyer
As the equity capital markets rocketed back into favour and global M&A saw at least a partial return to form, there have been some rich pickings for The Lawyer’s Corporate Team of the Year award shortlisted firms in 2014.
The city-state is working hard to become a global wealth management hub, and law firms are gearing up for a prosperous new world