The article highlights the key points related to the qualification of medical devices for the purpose of determination of their regulatory status, and also provides additional details regarding the most important concepts used.
Table of Contents
The UK Medicines & Healthcare products Regulatory Agency (MHRA), a country’s regulating authority responsible for medical devices, has published a guidance document dedicated to software and AI as a medical device change program. The document provides additional clarifications regarding the regulatory requirements for Software as a Medical Device (SaMD) products, as well as additional recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The guidance published by the MHRA describes the authority’s plans with respect to future guidance documents and policies to be issued in order to address known concerns and regulatory unclarity.
The scope of the guidance covers, inter alia, the aspects related to the qualification of products as SaMD and software in a medical device in order to ensure these products are regulated in an appropriate way. The authority acknowledges the lack of clarity existing nowadays with respect to the said matters, and thus provides additional explanations reasonably needed by the industry.
In particular, the authority intends to:
- Ensure medical device regulations capture the sufficient breadth of software to protect patients and public;
- Ensure there is sufficient clarity yet flexibility of qualification to effectively and proportionately regulate SaMD;
- To improve the wider regulation of digital health, through supporting and working with other regulators and processes where software does not qualify as a medical device.
SaMD Definition
First of all, the authority outlines the scope of products subject to regulation as SaMD. The MHRA is aware of the difficulties the parties involved face when determining the regulatory nature of medical devices, especially the ones that are similar to other categories of products. For instance, SaMD products could be confused with general well-being and lifestyle software products; medical device software could be confused with IVD [in vitro diagnostic] software. Specific rules also apply with respect to medical devices intended to be used for research purposes only, or custom-made devices. The current regulatory framework also provides special requirements for software in a kit, software system, software in a procedure pack, software as a service; and accessories to a medical device. The authority mentions its intent to improve manuals and guidelines on borderline products intended to assist medical device manufacturers and other parties involved in the determination of the regulatory status of the products in situations when this creates concerns.
Intended Purpose
One of the most important concepts used in the context of determination of the applicable regulatory framework is the concept of an intended purpose. The authority additionally emphasizes the vital importance of having it in place for the proper qualification of the product subject to review. At the same time, should the manufacturer fail to identify properly the intended purpose of the product, this could impact adversely further regulatory actions taken, including post-market surveillance activities.
The authority intends to develop additional guidelines intended to assist the parties involved in:
- Defining the intended purpose of the products they are responsible for;
- Avoiding common issues (e.g., the ones arising in case the device in question has multiple intended purposes);
- Identifying the intended use population;
- Understating the connection between the intended purpose and quality management system, and risk management; and
- Determining the proper way to revise the intended purpose when necessary.
Manufacturer
The roadmap developed by the MHRA also includes plans to introduce more clarity to the concept of a medical device manufacturer when it is used in the context of SaMD. Due to the specific nature of software products and the way they are created (developed) and modified, it is sometimes difficult to identify a specific entity to be deemed the manufacturer. As an example, the authority describes a situation when an open-source code is used for a SaMD product. According to the guidance, if the code is written and made available, then subsequently modified, the entity making the modified version may take on the responsibilities of the manufacturer of this modified code if it qualifies as a medical device. Hence, anyone using an open source code to create a software-based medical device will be deemed a medical device manufacturer and, consequently, will have to comply with any and all respective regulatory requirements and obligations medical device manufacturers are subject to.
The authority also intends to clarify the regulatory status of the entities involved in the deployment of SaMD products via third-party websites.
According to the guidance, the authority is planning to develop and implement a separate policy addressing all the important aspects related to the regulatory status of a medical device manufacturer in order to assist the parties involved in achieving and sustaining compliance with the respective requirements.
In summary, the present guidance is dedicated to specific aspects associated with the qualification of software-based medical devices and the determination of their regulatory status. The document also outlines the most important matters related to the key concepts used, such as the “intended use” or “medical device manufacturer” in order to ensure their proper interpretation.
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