The MHRA provides guidance notes on medical device stand-alone software (including apps) and it helps to clarify which types of apps should be classified as medical devices. It still requires developers to understand the implications of the EU Medical Device Directive (now the MDR) but helps to identify through the use of words and phrases which apps could be classed as medical devices. If you’re involved in developing a medical app then you should be considering compliance as part of your overall project as you will need assess if your app is classed as Software as a Medical Device (SaMD). If it is then it will need to be CE Marked.
We’ve created this short presentation to provide you with a quick guide to medical app regulation.