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.
From counting steps to helping healthcare professionals prescribe treatment for burns injuries, healthcare apps and stand-alone software are a part of everyday life. You might not realise depending on an unregulated app to provide a diagnosis or recommend treatment could have potentially life-threatening consequences. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance today to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe.