Technological advances in health care have placed software as an essential component of products and services for diagnostic and analysis of clinical conditions and diseases. Even when software has been included as part of medical devices, in recent years it has been an increased use of software as a medical device by its own. This situation has promoted the regulation of Software as a Medical Device (SaMD) by some regulatory agencies.
In 2013 the International Medical Device Regulators Forum (IMDRF) SaMD Working Group issued a document called “Software as a Medical Device (SaMD): Key Definitions” with the aim of creating a common definition for the software when it is considered a medical device.
According to point 5.0 of the above-mentioned document, the term “Software as a Medical Device” (SaMD) is defined as: software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Later in 2014, the IMDRF issued another document called “Software as a Medical Device”: Possible Framework for Risk Categorization and Corresponding Considerations with the objective of introducing a harmonized vocabulary and considerations for manufacturers, regulators, and users of SaMD.
Finally, in January of this year (2021), the IMDRF IVD Working group released the document titled Principles of In Vitro Diagnostic (IVD) Medical Devices Classification, in which SaMD is considered when it is used to process the output from an IVD Medical Device.
These three documents have been considered by IMDRF medical devices members as a basis for developing its own regulations, risk classification schemes and requirements.
Recently, there has been a significant development in the Mexican regulatory framework concerning SaMD. An update was made to one of the supplements of the Mexican Pharmacopoeia, which was published on the Official Journal of the Federation on May 5th, 2023. The update marks the first official stance regarding Software as a Medical Device taken by Mexico.
The latest edition of the Supplement for Medical Devices, Fifth Edition, of the Mexican Pharmacopoeia, ratifies the inclusion of SaMD as a category within Medical Devices: an instrument, apparatus, utensil, machine, including software for its operation, implantable product or material, diagnostic agent, material, substance, or similar product, to be used alone or in combination, directly or indirectly, in human beings for medical purposes.
Furthermore, the update provides a specific definition for SaMD:
“Software as a Medical Device (SaMD) refers to software used with one or more medical purposes, characterized by the fact that it does not need to be part of the hardware of a medical device to fulfill its intended medical purpose. SaMD is capable of functioning on general computerized platforms and can be used independently or in combination with other products (e.g., as a module, with another medical device, etc.). Mobile apps that fit within this definition are also considered SaMD. Software that facilitates the functioning of a medical device is excluded from this definition.”
In addition, a new rule for classifying medical devices has been implemented to address SaMD. Its classification criteria are based on the software’s involvement with a patient, and whether if it is critical to the patient’s health condition, or parameter determination. The classification for SaMDs can range from class I to III, depending on the specifications outlined in this new rule.
The FDA is a pioneer agency that has developed multiple guidance documents for SaMD regulation:
- Clinical evaluation
- Clinical Decision Support Software
- Device Software Functions and Mobile Medical Applications
- Medical Device Data Systems
Along with those documents, FDA has implemented policies and programs like the Digital Health Software Precertification (Pre-Cert) Pilot Program to help in the development of a future regulatory model for software-based medical devices by monitoring real-world performance of the products in the market.
According to the Medical Device definition described in the Article 2 of the Regulation (EU) 2017/745 on Medical Devices (MDR), software is subject to this regulation when it is used alone or in combination for medical purposes.
On the other hand, Article 2 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) also considers that software is subject to this regulation when used alone or in combination for in-vitro examination of specimens derived from the human body.
In October 2019, the Medical Device Coordination Group (MDCG) of the European Commission issued the document MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. The purpose of this document is to define the criteria for the classification of software within the scope of MDR and IVDR and to provide guidance to place the SaMD in the market, including applications for mobile phone or other platforms.
Two important definitions are mentioned in this document:
- Software: set of instructions that processes input data and creates output data.
- Medical Device Software (MDSW): software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device. MDSW may be independent, by having its own intended medical purpose and thus meeting the definition of a medical device or in vitro diagnostic medical device on its own.
In 2019, Health Canada issued a Guidance Document called Software as Medical Device (SaMD): Definition and Classification. The objective of this document is to clarify how SaMD fits into Health Canada’s regulatory framework for medical devices, based on current interpretation of the definition of “medical device” in the Medical Devices Regulations and the Food and Drugs Act.
Using the term Software as a Medical Device (SaMD) defined by the IMDRF, Health Canada considers that software is a medical device when:
- It is intended to be used for one or more medical purposes as outlined in the definition of device in the Act, and
- It performs these purposes without being part of a hardware medical device (i.e., it is not necessary for a hardware medical device to achieve its intended medical purpose).
The interpretation of the intended use is a key consideration in the determination of SaMD.
SaMD is a growing category of medical devices that involves new health care technologies. Therefore, regulatory agencies worldwide are recognizing the importance of establishing regulations and guidelines for safety and efficacy of software. Especially, when it is intended to be used as standalone for medical purposes.
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