Health Canada, the Canadian medical device regulating agency, has issued new guidance on software as a medical device (SaMD) to provide details on definition and classification.
The Scope of the Guidance
The new guidance describes certain aspects of the regulation of the software under Canada’s current legal framework. The document was first published for consultation in January 2019 and the feedback received was used to improve the initial version. The new guidance takes effect on December 18, 2019, and the agency has informed that this guidance is the first step in the course of implementing a new regulatory policy related to medical devices. The document is intended to assist manufacturers in preparing to submit the pre-marketing application. At the same time, the agency reserves the right to request additional documents rather than just what is described in the guidance, if the additional measures are necessary to confirm compliance with applicable safety and performance requirements.
The guidance provides classification rules that are based on the intended purpose of the software. The document also describes in detail how existing provisions that regulate the circulation of medical devices should be applied to issues related to SaMD. The agency intends to harmonize the regulation of SaMD with applicable regulations of other countries to simplify the process of placing the device on several markets simultaneously.
SaMD Definition
The main issue when performing the assessment of software is identifying whether or not the particular software subject to review falls within the scope of the existing regulatory framework. Thus, it is important to evaluate the functionality of the software, its intended purpose as specified by the manufacturer, and the manner it is represented, labeled or advertised. If at least one of the intended purposes claimed by the manufacturer constitutes the medical purpose as defined in the Food and Drugs Act, this software is a SaMD. The SaMD regulation utilizes the same risk-based approach that is used for other medical devices. Each medical function of the software must be evaluated separately and the highest risk level will be deemed as the risk classification of the software as a whole.
Depending on the type, the SaMD can be either used on general hardware that is not a medical device (such as personal computers, tablets or smartphones) solely or in connection with other medical devices or other SaMD. Current regulation covers only the software that can be sold and supplied in any way including downloading from the website. Software-as-a-service and solutions that are accessible online fall outside the scope of the present guidance, as well as the software that manages the operations of the hardware medical device itself.
The guidance provides the list of important definitions, namely:
- Software as a Medical Device (SaMD) – software intended for one or more medical purposes that is not a direct part of a medical device. It is important to mention mobile apps that meet the aforementioned criteria could be defined as SaMD.
- Medical Device Data System – includes both hardware and software solutions intended to transfer, store or process medical data without making changes to it.
- Clinical Decision Support Software – intended to be used by healthcare professionals.
- Patient Decision Support Software e.i. intended to be used by users that are not professionals. It is also important to mention that the agency defines the user as a patient that is not under the supervision of a healthcare professional.
The definition used by the agency has been initially developed by the International Medical Devices Regulators Forum (IMDRF), a group constituting medical device regulators aimed at the improvement of the framework and its harmonization. The concept of intended use is one of the core elements of the SaMD definition and there are several approaches to its interpretation. According to the position of the agency, the software intended for medical purposes is a software intended to:
- Acquire or process signal or image from the medical device, or
- Provide recommendations to healthcare professionals.
At the same time, the guidance provides a wide list of exclusions, such as:
- General administrative software used by healthcare institutions,
- Software used for communications,
- Wellness apps and similar software,
- Software intended to manage records or information in other forms.
The software that falls within the scope of the exclusions provided above is not a SaMD. At the same time, the agency also provides an additional list of flexible criteria to be applied in complicated cases when the medical intended purpose is unclear. The agency also states that other factors could be evaluated when making the final decision.
Important Aspects of SaMD Classification
If the software has been defined as the SaMD, it should be properly classified in accordance with the risk-based classification taking into consideration certain aspects related to software specifics.
Each particular SaMD should have its own classification even if it is a component of other systems, and it could also have several functions subject to a different classification. The initial classification should be performed by the manufacturer while the Medical Device Bureau would check whether it is correct during the application review. Despite the manufacturer`s right to file a request for additional assessment to change the classification but in case of any discrepancies, the classification defined by the agency should prevail.
When performing the classification of the software, the agency makes its decision based on the following information:
- The role of the information provided by the software and the way it is used in diagnosing or treating disorders. There are three types of software depending on the significance of the information provided: diagnosis and treatment purposes, providing clinical/patient management and informing clinical/patient management.
- The situation or circumstances under which the software should be used. For example, the software intended to be used in critical situations should be classified in accordance with the high risk associated with it. There are three subcategories, including critical, serious and non-serious conditions.
- The functionality of the software.
It is also important to mention that medical device software meets the definition of an active device since it requires to be connected to the source of energy.
The definition of SaMD also includes the software intended for in vitro diagnostic purposes (IVD), so the same classification rules are applicable for the software of this type, including the risk factors that should be evaluated. The agency confirms that all IVD device classification rules could be applied for the classification of the software except the rule on “near-patient device” as one intended for home use. The rule has been excluded since most of the SaMD is intended to be used outside the laboratories that makes the application of this criterion inappropriate for classification purposes.
The guidance also includes a list of other documents that could be useful for medical device manufacturers and other parties involved to familiarize with the regulatory framework and to maintain compliance with applicable requirements.
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