MHRA guidance on medical device stand-alone software

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.

This guidance:

  • 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.

Best wishes,
Dr Karla Duarte
Infrastructure Team Leader
NIHR Office for Clinical Research Infrastructure (NOCRI)
NOCRI twitter