The UK Medicines and Healthcare products Regulatory Authority (MHRA) has, on 5 June 2020, published new guidance[1] on the regulatory status of software, including apps, used during the COVID-19 pandemic. The new guidance builds on specific MHRA guidance[2] manufacturers and developers on medical device stand-alone software including apps.
Software classed as medical devices
‘Software’ refers to a set of instructions that processes input data and creates output data. Where software meets the definition of a medical device it must be CE marked so as to demonstrate it is acceptably safe to use and perform in the way the manufacturer/developer intends. Types of software likely to be classified as a medical device include:
- 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); and
- software and apps to support clinical decision making.
However, software and apps used to record patient details (e.g. patient diaries) and well-being apps (e.g. general relaxation to treat stress) are unlikely to be classified as medical devices because their manufacturers do not make medical claims.
The guidance is split into advice for manufacturers[3] and advice for members of the public and professional users[4].
Advice for manufacturers
For manufacturers of software and apps which are CE marked for purposes other than COVID-19, but which might be used in connection with the pandemic, the MHRA has introduced COVID-19 regulatory flexibilities[5] providing options to make exceptional use applications. Manufacturers may also be able to apply for expedited clinical investigation in order to gain clinical data. There is no need to apply to the MHRA for CE-marked software or apps where there is only a limited change to its intended use, e.g. a change to the clinical-use setting (although manufacturers should perform a risk assessment).
For software and apps developed specifically in response to COVID-19, where likely to be a medical device, an exceptional use authorisation or derogation exemption may be available to the developer prior to full CE product marking. In seeking authorisation/derogation, developers must show evidence of:
- risk management systems;
- quality management systems;
- evidence of meeting the relevant essential requirements of the Medical Devices Directive or In Vitro Diagnostic Medical Devices Directive; and
- post-market surveillance plan.
Advice for members of the public and professional users
The guidance is intended to help the public identify where software or apps have a medical purpose. Such medical devices must be CE marked to show that they conform to medical requirements, are fit for their intended purpose and meet safety legislation. The guidance also speaks to the actions to be taken where things go wrong including reporting incidents involving medical devices related to COVID-19 treatment via the MHRA’s dedicated Yellow Card coronavirus reporting website[6].
Further advice and guidance
In our experience, the MHRA adopt a very proactive, helpful and supportive approach and manufacturers and developers are asked to contact them as early as possible if they require further guidance by email to devices.regulatory@mhra.gov.uk.
If you would like more information about the latest MHRA guidance on software/apps as medical devices, please contact the author or your usual Fladgate contact.
[1] https://www.gov.uk/government/publications/regulatory-status-of-software-including-apps-used-in-the-diagnosis-treatment-and-management-of-patients-with-coronavirus-covid-19?utm_source=38a2e325-85c0-4d69-af36-1bd63ed33df8&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
[2] https://www.gov.uk/government/publications/medical-devices-software-applications-apps
[3] https://www.gov.uk/government/publications/regulatory-status-of-software-including-apps-used-in-the-diagnosis-treatment-and-management-of-patients-with-coronavirus-covid-19/advice-for-manufacturers-software-and-apps-used-in-covid-19-pandemic
[4] https://www.gov.uk/government/publications/regulatory-status-of-software-including-apps-used-in-the-diagnosis-treatment-and-management-of-patients-with-coronavirus-covid-19/advice-for-members-of-the-public-and-professional-users-software-and-apps-used-in-covid-19-pandemic
[5] https://www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak
