MHRA Discusses the Latest UK Regulatory Guidance on Healthcare Apps at European Healthcare Apps Summit
LONDON, April 8, 2014 /PRNewswire/ --
David Grainger, Senior Medical Device Specialist at MHRA has just confirmed his attendance as a speaker at the Healthcare Apps Summit taking place from 28th -30th April in London, UK.
http://www.healthcareappseurope.com/news
Following the latest UK Regulatory Guidance on Healthcare Apps and Medical Devices, Grainger will share first-hand insights on understanding the latest changes in regulation, their implications on medical apps and how to adhere to the new rules.
When is your App a Medical Device?
In January 2012, the European Commission (EC) published a set of guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices. These guidelines helped manufacturers, software developer, academics, clinicians and organisations decide if their software was a medical device or an in vitro diagnostic.
The latest MHRA's guidance, explains how these technologies are regulated, covers a range of definitions which are intended to clarify which regulatory pathways app and software makers should use to bring their devices to market.
Apps aren't excluded from this definition, and those meeting MHRA's definition of "medical device" will need to undergo the conformity assessment (CE) process before being allowed on the market.
The Healthcare Apps Summit takes place on 28th - 30th April 2014 at the DoubleTree by Hilton Hotel - Victoria, London, United Kingdom. Find the agenda, event details and registration information about the summit on http://www.healthcareappseurope.com/news, phone +44-(0)20-7036-1300 or email enquire@iqpc.co.uk
Media contact: Veronica Araujo, +44-(0)20-7368-9748, veronica.araujo@iqpc.co.uk or visit http://www.healthcareappseurope.com/news
Press are invited to attend this important industry forum, if you would like to a complimentary press pass please email Veronica Araujo veronica.araujo@iqpc.co.uk
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