MHRA provided advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic.

Standalone software and apps that meet the definition of a medical device are required to be CE marked in order to demonstrate that they are acceptably safe to use and perform in the way the manufacturer/developer intends them to.

The following types of software are likely to be classed as medical devices:

  • software (including artificial intelligence) and apps (either incorporated into an existing device or supplied separately) that are used for contributing to diagnostic processes
  • software and apps for helping patients to manage their health conditions like diabetes, cancer or mental health issues
  • software and apps for monitoring patients (including remotely)
  • software and apps to support clinical decision making

MHRA previously published specific software guidance on medical device stand-alone software including apps.

For more details, please see the original guidance from MHRA.

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

Contact Meditrial for immediate assistance in Europe or the US.

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