The Medicines and Healthcare products Regulatory Agency (“MHRA”) has updated its guidance on stand-alone software including apps (the “Updated Guidance”). The Updated Guidance sets out the MHRA’s interpretation of the Medical Devices Directive (93/42/EEC) and In Vitro Diagnostics Directive (98/79/EC) in relation to software products (including apps). The Updated Guidance replaces previous 2014 guidance. It is designed to be used online and by a wider range of stakeholders. It will be particularly useful to app developers and medical device manufacturers looking to determine whether an app falls within the definitions of a 'medical device' or 'in vitro diagnostic medical device' (“IVD”) for the purposes of the EU medical devices legislation. It also provides guidance on the applicable requirements for marketing such medical device / IVD software.
The Updated Guidance represents the MHRA’s interpretation of the European Commission’s 2012 MEDDEV 2.1/6 on the qualification and classification of stand-alone software. Neither guidance document is legally binding but each provides an indication of how the devices legislation will likely be interpreted by the UK regulator in the context of stand-alone medical software.
Helpfully, the Updated Guidance has been published in a new ‘interactive PDF’ format that makes it easier for the reader to find the relevant definitions and associated information from the links within the document. The guidance also makes use of decision trees to help users ascertain whether a piece of software falls within the definition of either a medical device or an IVD.
Notably, the existing EU medical devices legislation does not include a definition of 'software' and the 2014 guidance did not elaborate on this term. The Updated Guidance now asks readers to determine whether the product is a 'computer program' (by reference to the definition contained in ISO/IEC 2382:2015) or a 'functional document'. It thus provides more concrete guidance on what is likely to be classed as software under the legislation.
An interesting new addition is a section aimed at users of health-related apps. This includes guidance on checking whether an app is regulated as a medical device and is CE-marked and also a reminder to check the privacy terms upon which the user provides his/her personal data when using the app.
When is an app a medical device?
For an app to fall within the definition of a medical device under the EU medical devices legislation, it must have as its intended purpose one or more of the “medical purpose(s)” set out in the relevant directive. This requirement has led to difficulty in classifying many apps, as there is often ambiguity as to when the purpose of a general health or wellbeing app becomes a medical purpose. Responding to the proliferation of such apps in recent years, the Updated Guidance provides considerably more detailed guidance on these points and includes examples of what is likely to be covered by each purpose and what is outside the scope of the legislation. The increase in examples contained in the Updated Guidance likely reflects the rate of technological innovation since the 2014 guidance.
The Updated Guidance also includes some helpful clarification as to the MHRA’s own approach. For example, in order to fall within one of the medical purposes in the legislation, the app must be linked to a specific disease, injury or handicap. This will give some comfort to developers of more general wellbeing and health monitoring apps that their apps are not likely to be regulated as medical devices or IVDs.
Other useful clarifications include the lists of synonyms and phrases which relate to each of the medical purposes in the legislation. These indicate the MHRA’s interpretation of the scope of those terms. For example, for the legislation’s medical purpose of ‘diagnosis’, the Updated Guidance clarifies that terms such as ‘triage’ and ‘screening’ will be considered synonymous.
Developers and licensees should also note the guidance in relation to disclaimers that seek to avoid the product being regulated as a medical device. The Updated Guidance maintains the MHRA’s previously stated view that if an app qualifies as a medical device and is placed on the market for a medical purpose, it will still need to comply with the relevant directive regardless of any disclaimer which may be used by the developer.
Guidance on compliance with legal requirements
Whilst there was limited guidance in the 2014 guidance on how to comply with the directives should a software product be regulated as a device, the Updated Guidance provides advice in relation to meeting the requirements in the legislation. Before a device or IVD can be placed on the market the manufacturer must be able to demonstrate that it meets all of the applicable ‘essential requirements’. The Updated Guidance highlights the essential requirements that are likely to apply to stand-alone software. It also includes annotations to help the understanding of what is required by certain of these essential requirements.
The Updated Guidance may turn out to have a relatively short shelf-life as the Updated Guidance only provides guidance on interpretation of the existing EU medical devices legislation. The new EU Medical Devices Regulation and EU In Vitro Diagnostics Regulation, which are expected to be adopted in 2016, will replace the current directives and come into effect over the course of a three to five year implementation period post-adoption. Guidance will then need to be updated to take account of the changes brought in by the new EU Regulations. Nonetheless, in the interim, the Updated Guidance will likely prove useful to a range of stakeholders in the health-app field by bringing further clarity to determining how apps will be regulated.