bio_subbu
Super Moderator
Dear All
The UK's MHRA (Medicines and Healthcare Products Regulatory Agency) has published a new guidance document titled "Guidance on medical device stand-alone software (including apps)" on 20th March 2014. The guidance aims to outline the current regulatory position, explain what defines a medical device, help with decisions on whether the standalone software/SW application is meeting the definition of medical device, give information about the rules on classification of medical devices and how to meet the regulations & give links to other useful websites and relevant guidance documents. Also the document discusses apps, decision aids and telehealth.
For more information, refer below MHRA links;
http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON395239
http://www.mhra.gov.uk/Howweregulate/Devices/Software/index.htm
The UK's MHRA (Medicines and Healthcare Products Regulatory Agency) has published a new guidance document titled "Guidance on medical device stand-alone software (including apps)" on 20th March 2014. The guidance aims to outline the current regulatory position, explain what defines a medical device, help with decisions on whether the standalone software/SW application is meeting the definition of medical device, give information about the rules on classification of medical devices and how to meet the regulations & give links to other useful websites and relevant guidance documents. Also the document discusses apps, decision aids and telehealth.
For more information, refer below MHRA links;
http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON395239
http://www.mhra.gov.uk/Howweregulate/Devices/Software/index.htm
