Following a trend in several markets with well-developed regulatory frameworks, the UK Medicines and Healthcare products Regulatory Agency (MHRA), has evolved its medical device regulatory framework in consideration of the technological developments and advancements in the software industry, particularly in the case of apps and the utilization of multipurpose products (e.g., Microsoft Word or Microsoft Excel) for medical purposes. If medical claims are made or implied in product labeling or associated promotional materials, no disclaimers (such as stating that the product is for “information only” or “for research use only”) can reduce a manufacturer’s responsibilities.
Interpreting stand-alone software under the UK MHRA
In this article, we cover some of the considerations for developers of stand-alone software under the UK regulatory framework based upon current MHRA guidelines, which are the regulatory authority’s interpretation of MEDDEV 2.1/6 concerning qualification and classification of standalone software.
Defining medical device software systems and modules under the MHRA
While no definition has been established in the UK Medical Device Regulations 2002 (UK MDR 2002) for ‘system’ there are specific requirements for UKCA/CE marked and non-UKCA/CE marked products placed on the market together. For example, where a combination of a tablet (not a medical device) pre-loaded with medical device software (medical device or accessory) and physiological monitoring hardware (medical device) is placed on the market together, this combination would be considered a ‘system’ in the UK. Where the software is provided as part of an in vitro diagnostic (IVD) medical device (IVDMD) system (or IVD kit) it would be considered as an IVDMD.
In the case of multi-modular software, it is generally recommended that manufacturers assess the functions and purposes of each module on a case-by-case basis to determine whether they fall within the definition of a medical device and are subject to regulatory oversight by the MHRA rather than marking the entire software as a device. This also assists manufacturers to more clearly apply the risk classification rules for such software.
Is the software an accessory to a device or a device component?
The definition of ‘accessory’ under the UK MDR 2002 is aligned with that under the EU regulatory framework. It requires that the ‘accessory’ product is specifically intended by its manufacturer to be used together with one or several devices, to enable the device(s) to fulfill its/their intended function. However, care does need to be taken when determining whether the software is a device accessory or component. For example, where an app is the only way in which a user or patient can interact with a hardware device (e.g., a physiological monitoring device with no output display that wirelessly links to a mobile device on which the app is installed) such as displaying, storing and analyzing data, then this software may be considered a device component.
Does the software have a medical purpose?
If the software has one or more of the following functions, it has a medical purpose under the UK MDR 2002 and is regulated as either a medical device or IVDMD depending upon its function(s):
Where software only has one or more of the following functions (and where all functions listed above have been ruled out), it does not have a medical purpose:
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- Patient medical education
- Monitors fitness/health wellbeing
- Professional medical education
- Stores or transmits medical data without change
- Software that is used to book an appointment, request a prescription or have a virtual consultation is also unlikely to be considered a medical device if it only has an administrative function. An electronic patient record that simply replaces a patient’s paper file does not meet the definition of a medical device
- Software that provides reference information to help a Healthcare Professional to use their knowledge to make a clinical decision
- Databases without internal language/macros/scripting
A case in point regarding the function under the last bullet point above is multipurpose products such as Microsoft Excel. While Microsoft Excel itself is not a medical device, if a spreadsheet running in this program has a specific clinical intended purpose reliant upon the use of macros, functions or Visual Basic, it could have a medical purpose and therefore be considered a medical device.
Furthermore, the software under UK MHRA is unlikely to be a medical device if:
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- It simply reproduces a paper document in digital format, whereby a healthcare professional decides based on the data displayed
- It simply follows the path of a procedure/treatment – there are no decisions made by the software – it may provide information
- It has decision points and options that may be explained, however, the healthcare professional determines the applicable decision pathway
- It offers only lifestyle treatment choices or referral advice, such as contacting your healthcare professional
Medical device or IVDMD?
Once a manufacturer has determined that its software has a medical purpose it then must determine, again based upon its intended purpose, whether the software is subject to regulatory oversight as a medical device or IVDMD. This is straightforward to determine where the software does not possess any of the IVD medical purposes established in the UK MDR 2002 but becomes challenging for multi-purpose software or where the software output is driven by data generated by a medical device and IVDMD.
Where the software uses IVD data that are results originating from historical investigations unrelated to the software, then the software is considered a medical device. Where the output of the software is substantially driven by IVD data it will be considered to be an IVDMD, otherwise it will be a medical device. When determining whether the software output is substantially driven by IVD data, manufacturers should assess the significance of each predictor. While this could comprise an assessment of the weighting of different parameters in a software algorithm, this assessment may be complex, particularly where variables may not scale linearly with a simple weighting factor. The manufacturer must document their rationale (with supporting evidence) when determining whether software output is substantially driven by IVD data (or not). A statistical-based approach is strongly recommended.
Learn more about UK MHRA Stand-alone Software with Medenvoy
If you have any questions regarding placing your software devices on the UK market, require relevant training or consulting services, or are looking for a UK Responsible Person to contract, get in touch.