The article provides a brief overview of an updated guidance document issued by the UK regulating authority with respect to software products subject to regulation as medical devices.
Table of Contents
The Medicines & Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published an interactive guidance document dedicated to medical device stand-alone software, including apps. The scope of the guidance also covers the regulatory matters associated with in vitro diagnostic (IVD) medical devices. The guidance is intended to provide medical device manufacturers (software developers) with additional clarifications regarding the applicable regulatory requirements and recommendations to be considered to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
In particular, the guidance outlines the scope of products that meet the definition of a medical device and, consequently, are subject to regulation under the respective framework and also describes the applicable requirements in terms of marking what such products should comply with. It is important to mention that CE-marked medical devices will be accepted beyond 30 June 2023. The document also states that the recommendations provided therein are relevant for the products to be marketed and used in England, Wales, and Scotland, while for Northern Ireland, different rules apply.
Regulatory Background
First of all, the authority acknowledges the increasing role of medical device apps that are currently widely used for various purposes when providing healthcare services. Under the applicable national legislation, should a standalone software meets the definition of a medical device, it will be subject to UKCA marking as prescribed in the Medical Device Regulations 2002 (UK MDR 2002) to ensure their compliance with the applicable regulatory requirements in terms of safety and effectiveness.
In order to assist medical device manufacturers in determining whether the products they are going to place on the market are subject to regulation as medical devices, the authority provides detailed recommendations and flowcharts demonstrating the approach to be applied. Apart from that, the guidance provides additional clarifications regarding the classification of medical devices and outlines the key points to be considered to facilitate the review of the marketing submission.
Regulatory Status
According to the flowchart provided by the authority, the main factors to be considered when determining the regulatory status of the product are:
- Whether the product in question works in combination with one or more devices;
- Does it have a medical purpose;
- Whether it enables the function of the device (an accessory);
- Does it qualify as an in vitro diagnostic medical device;
- Where the other device the product works with is an active implantable device.
Terms and Definitions
The document also provides definitions of the most important concepts used in the context of software products, including, inter alia, the following ones:
- Functional document – software that requires separate software to perform its function.
- Accessory – a product intended to enable a medical device to fulfill its intended function, and it will be treated as a device under the UK MDR 2002.
The document also describes such concepts as “medical device system” and “module”.
General Rules
The authority also highlights some general rules applicable to all medical devices subject to regulation under the existing framework.
For instance, all medical devices are subject to classification rules to be used by their manufacturers in order to determine the requirements to comply with. Existing classification rules provide the following classes:
- Class I – generally regarded as low risk;
- Class IIa – generally regarded as a medium risk;
- Class IIb – generally regarded as a medium risk;
- Class III – generally regarded as high risk.
Based on the applicable classification, the device should comply with the essential requirements to ensure safety and proper performance when used for the intended purpose. The authority also mentions that medical device manufacturers may refer to the relevant standards in order to demonstrate compliance with the respective essential requirements.
Once the product becomes available for marketing and uses in the country, its manufacturer becomes responsible for continuously monitoring and notifying the authority about adverse events. Additional clarifications regarding the reporting rules and requirements are provided in a separate guidance document issued by the MHRA.
The authority additionally emphasizes that accessories to medical devices are treated as medical devices. Hence, all the relevant regulatory requirements will apply.
Classification Rules: Specific Aspects
When it takes to software-based products, the authority clarifies how existing classification rules should be applied. For instance:
- Software, which drives a device or influences the use of a device, automatically falls into the classification of that device.
- All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb.
In summary, the present MHRA guidance provides an overview of the regulatory requirements to be applied with respect to software products subject to regulation as medical devices under the existing framework. The document outlines the key points to be considered by medical device manufacturers and other parties involved to ensure proper interpretation of the relevant provisions of the applicable legislation, as well as continued compliance thereto.
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