MHRA set apps guidelines

March 23, 2014

The guidelines are aimed at healthcare and medical software developers where they are unsure of the regulatory requirements for CE marking stand-alone software as a medical device. 

The guidelines explain how this technology is regulated, and covers what is known as "stand-alone software" (also known as software as a medical device). It does not include software that is part of an existing medical device for example software that controls a CT scanner.

Full details can be found at http://www.mhra.gov.uk/Howweregulate/Devices/Software/index.htm

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