The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on medical device standalone software last month.

It’s been updated with new guidance on a range of hot topics in the digital health space, including:

  • clinical calculators;
  • the interpretation of ‘direct diagnosis’ when classifying medical devices;
  • prescription software and the ruling in Snitem v Philips France C-329/16;
  • software which drives a device or influences device use; and
  • control of conception apps.

We've set out our top 5 takeaways from the advice in our blogpost here.