Software as MD: Regulatory guidance from UK

The UK MHRA has published the revised Guidance on medical device standalone software, including apps.

The flowchart was created to help manufacturers understand better their specific obligations as well as assist in classifying a software, an app as a medical device  – while suggesting appropriate claims that should accompany such devices.

The MHRA Guidance was created under the Directives, however we would like to bring to your attention the List of novelties introduced by the new MDR, which you can consult here.

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