The Medicines and Healthcare Products Regulatory Agency (MHRA) guidance document: Medical device stand-alone software including apps (including IVDMDs) serves as a replacement for the previous MHRA guidance on medical device standalone software and apps. It acknowledges the increasing use of medical device apps in healthcare management, fitness regimes, and social care situations. In the UK, standalone software and apps that meet the definition of a medical device are still required to be UKCA marked under the UK MDR 2002 to ensure regulatory compliance and safety. The document provides guidance on determining whether apps qualify as medical devices and includes flowcharts to illustrate which software and apps require UKCA marking. It also offers information on classification, the UKCA marking process for developers, and responsibilities for reporting and correcting issues. This guidance should be used alongside MEDDEV 2.1/6 and represents the UK's interpretation of the guidance.
- Device Decision Flow Chart
The guidance document is intended to be interactive, providing medical device manufacturers with multiple interactive flow charts. The first flow chart enables a medical device manufacturer to assess whether their standalone software or app qualifies as a medical device. To effectively utilize the flow chart, the user needs to grasp several definitions beforehand.
Computer Program: syntactic unit that conforms to the rules of a particular programming language and that is composed of declarations and statements or instructions needed to solve a certain function, task, or problem.
Functional Document: Software that requires separate software to perform its function.
Accessories: An accessory is a product intended to enable a medical device to fulfil its intended function and it will be treated as a device under the UK MDR 2002.
Systems: There is no definition of a ‘system’ in the UK MDR 2002 but there are specific requirements for products placed on the market that combine UKCA/CE marked devices and non-UKCA/CE marked products.
Modules: In complex systems it may be appropriate to UKCA mark only those functions/modules that meet the definition of a device rather than UKCA marking the whole product.
- Medical Purpose Flow Chart
When using the Device Decision Flow Chart, the manufacturer will encounter a question regarding whether the standalone software or app serves a medical purpose. But what does this mean?
A medical purpose is determined by what the manufacturer communicates through the device's labeling, instructions for use, and promotional materials.
For instance, monitoring general fitness, general health, and general wellbeing is typically not considered a medical purpose.
Software is unlikely to be classified as a medical device:
- It merely digitizes a paper document without providing decision-making authority, the responsibility lies with the healthcare professional who makes decisions based on the displayed advice.
- It simply follows a predetermined procedure or treatment without involving decision-making, it may provide information but does not make decisions.
- It includes decision points and presents options with explanations; the healthcare professional ultimately chooses the path to follow.
- It only offers choices related to lifestyle treatment or referral advice (e.g., recommending seeing a general practitioner).
Software is likely to be classified as a medical device if:
- It is connected to a particular medicine or device, indicating that it may function as an accessory to that product.
- Its intended purpose is to impact the actual treatment process, such as determining the appropriate dosage, size of implant, or timing of treatment.
- It yields a diagnosis or prognosis, offering information about the future risk of a disease.
A separate flow chart is provided specifically for invitro diagnostics.
- Medical Devices
The guidance provides information for software and apps that qualify as medical devices and need to comply with UKCA marking requirements. It includes the following key points:
I. Classification: Manufacturers need to determine the classification of their medical devices based on the regulations. There are four classes (Class I, IIa, IIb, and III), each associated with a different level of risk.
II. Essential Requirements: The software or app must fulfill the general essential requirements and specific design and construction requirements outlined in the regulations. This guidance lists the essential requirements that are likely to be applicable to software and apps. Manufacturers can use relevant designated standards to demonstrate compliance with these requirements.
III. Post-market Surveillance: After a medical device is introduced to the UK market, the manufacturer is responsible for monitoring the product and reporting any serious adverse incidents to the MHRA (Medicines and Healthcare Products Regulatory Agency). The guidance provides information on how to report adverse incidents. This monitoring ensures the ongoing safety of the device while it is being used.
It is important to note that accessories are considered medical devices and are subject to all relevant requirements outlined in the guidance.
The guidance aims to assist manufacturers of software and apps that qualify as in-vitro diagnostic medical devices in meeting the UKCA marking requirements.
I. Categories: Manufacturers of in-vitro diagnostic medical devices need to determine the specific category to which their software belongs, as it determines the compliance route. There are four categories:
a) General IVDs
b) IVDs for self-testing
c) IVDs in List A
d) IVDs in List B
II. Essential requirements: The software must meet all the general essential requirements and the relevant design and manufacturing requirements outlined in the UK MDR 2002, Annex I (as modified by Part 3 of Schedule 2A to the UK MDR 2002). This guidance provides a list of essential requirements likely to be applicable to software and apps. Manufacturers may use relevant Designated standards (external link) to demonstrate compliance with these requirements, if available.
III. Post-market Surveillance: Once an in-vitro diagnostic medical device is introduced to the UK market, the manufacturer assumes responsibility for monitoring the product and reporting any serious adverse incidents to the MHRA. Guidance on reporting adverse incidents provides information on the reporting process. This ensures the device remains safe for use throughout its lifespan.
- Active implantable Medical Devices
Accessory software for an Active implantable medical device should be treated as an Active implantable medical device. Further guidance is provided in guidance MEDDEV 2. 1/2 rev 2.
The MHRA guidance on standalone software and apps addresses the increasing use of medical device software in various healthcare settings. The document emphasizes the importance of UKCA marking for software and apps that meet the definition of a medical device, ensuring regulatory compliance and safety. It provides helpful flowcharts to assist manufacturers in determining whether their software qualifies as a medical device and offers guidance on classification, essential requirements, and post-market surveillance. Users are also provided with tips on identifying medical devices, ensuring appropriate marking, and reporting issues. By following this comprehensive guidance, manufacturers and users can navigate the regulatory landscape and contribute to the safe and effective use of medical device software and apps in the UK.
Trevor Klemann – Associate Medical Device Consultant