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When does software become a medical device? Guidance for manufacturers

Technological advancement in medical devices has created a rise in the creation of a host of new software and apps, with a number of key factors to consider before these can go to market.

What is the existing regulatory framework?

The current UK regulatory framework relevant to medical devices is primarily the Medical Devices Regulations 2002 (UK MDR).

On the EU level, medical devices legislation is currently transitioning from a regime governed by the Medical Devices Directive 93/42/EEC (MDD) to a unified regime governed by the new Medical Devices Regulation 2017/745/EU (EU MDR) and the EU In vitro Diagnostic Regulation (Regulation (EU) 2017/746). For purposes of this article, we focus on medical devices rather than in vitro diagnostic devices.

The EU MDR would have come into force on 26 May 2020, but due to the COVID-19 pandemic, the date of commencement was extended by one year to 26 May 2021. Before this date, medical devices can be certified under either the old or new regimes. After this date, new medical devices will need to be certified under the new EU MDR regime.

The new commencement date of the EU MDR falls beyond the Brexit transition period agreed with the EU and will therefore not automatically become part of UK law. See further here for a flavour of how Brexit may affect the UK regulatory landscape pertaining to medical devices.

When will software be a medical device?

This is largely a question of fact and if it fits in the definition of a ‘medical device’. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on this topic, which provides a practical guide on how to determine if software amounts to a medical device. With regard to the effect of Brexit, such guidance also states that the MHRA will provide further guidance on this in due course. In the meantime, the existing regulatory requirements should continue to be met.

The definition of a ‘medical device’ under the UK MDR is broad. In general, medical devices must have a ‘medical purpose’; they must also act primarily in a way that is not metabolic, immunological or pharmacological. Medical devices are further considered to be items intended to be used in a ‘medical’ context.

Whether or not a product is considered to have a ‘medical purpose’ will be defined by the manufacturer’s intention for the product, as defined in their labelling, instructions for use and promotional material and its mode of action in conjunction with the definition of a medical device.

Software/apps will have a ‘medical purpose’ if, for example, it relates to the diagnosis of disease, an injury or handicap. For example, in the context of skin conditions, if the software/app is intended to be used to diagnose/assess/monitor a skin condition by interpreting images taken of the skin that are imported into the app, it is likely that such software/app will be considered a medical device. By contrast, where the software/app merely stores/records these images for subsequent review by a clinician, such software/app will not be a medical device.

In the UK (and throughout Europe), standalone software and apps that meet the definition of a medical device are still required to be CE marked in order to ensure they are regulated and safe to use and also perform in the way the manufacturer intends them to. CE marking will be dealt with differently in Great Britain post-Brexit.

Are there any COVID-19 implications?

COVID-19 has given rise to a number of apps that monitor patient conditions remotely as well as new digital healthcare systems to assist patients from the comfort of their home. As is the case with other medical devices, where a software or an app has a role in responding to the current COVID-19 pandemic, but is not CE marked for this purpose, the manufacturer may be able to use the MHRA’s COVID-19 related regulatory flexibilities. More information can be found here.

Each matter is dealt with on a case by case basis. If there is a significant change to the intended purpose of a CE marked app or software, manufacturers may also be able to apply for the device to be part of an expedited clinical investigation in order to gain clinical data. If the device is already CE marked and there is only a limited change, for example a change to the clinical use setting, then there is no expectation for a request for exemption. More information can be found here.

The requirements mentioned in this article are continuously changing and developing. Please do not hesitate to contact Pieter Erasmus or Rumana Khanom should you require any assistance or have any further questions.

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