MHRA Guidance on Medical device stand-alone software updated

2018/06/20
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its interactive guidance on stand-alone software and health apps.
This update includes a new appendix on symptom checkers, contains edits to the introduction and diagnosis pages (pages 4 & 19) as well as new links related to the General Data Protection Regulation (GDPR).

In the new appendix, symptom checkers are defined as independent software intended for use by lay users in which the user manually enters details/symptoms and the software algorithm matches these with conditions.
Symptom checker outputs include:
  • A list of all matching conditions, likely conditions, most likely condition etc.
  • An indication of seriousness – e.g. “Red flag”.
  • Recommended treatments.
  • Triage “signposting” of next steps, e.g. visit General Practitioner.
Symptom checker devices that are qualified as a medical device will be class I unless considered to “allow direct diagnosis”, in which case they will be class IIa.

What does this mean to you?
MHRA’s interactive guidance on “Medical device stand-alone software including apps” is a useful tool to determine if the software/app you have developed is considered a medical device or an in vitro diagnostic medical device (IVD).

Please note that this is a tool, in no way legally enforceable or binding, developed by a single EU member state regulator. Manufacturers are advised to first and foremost use the guidelines contained in the MEDDEV 2.1/6 “Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices”.

In brief, the MEDDEV 2.1/6 states that stand-alone software must have a medical purpose, for the benefit of the individual or patient, to be qualified as a medical device. If the software does not perform an action on data, or performs an action limited to storage, archival, communication, “simple search” or lossless compression it is not a medical device. If the stand-alone software has a medical purpose based on data coming from an IVD, or a combination of IVDs and medical devices, it must comply to the IVD Directive 98/79/EC. If the data comes solely from medical devices it must comply to the MDD 93/42/EEC.

Don’t hesitate to contact us for more information or for support in classifying your products

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