The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued guidance for healthcare and medical software developers who are unsure of the regulatory requirements for CE marking stand-alone software as a medical device.
- outlines the current regulatory position
- explains what defines a medical device
- helps with decisions on whether your stand-alone software or app is a medical device and gives examples
- gives information about the rules on classification of medical devices and how to meet the regulations
- provides links to other useful websites and relevant documents.
This guidance is aimed at healthcare workers and device manufacturers, and explains how this technology is regulated.
It covers stand-alone software (also known as software as a medical device) but not software that is part of an existing medical device because this is seen to be part of the device, e.g. software that controls a CT scanner.
View the MHRA’s guidance here.