The regulatory landscape for AI-driven medical software is constantly evolving, with new frameworks, guidelines, and requirements emerging across different regions.
Companies operating in this space must adapt to these changes while ensuring compliance with various national and international regulations. Infermedica addresses these challenges through a structured and proactive approach.
Are Infermedica’s solutions considered medical devices in the US and EU?
The regulatory status of Infermedica’s solutions varies across different countries. While all products are developed under a Quality Management System, based on ISO 13485, not all of them fall under local medical device regulations in every jurisdiction.
The most significant regulatory differences exist between the United States and the European Union. In the U.S., the FDA provides a guideline that allows enforcement discretion for low-risk software with a specific intended purpose.
Infermedica defines its device's intended purpose as, “Software functions that guide a user through a questionnaire of signs and symptoms to provide a recommendation for the type of health care facility most appropriate to their needs,” meaning its products remain outside the FDA clearance process. This classification allows Infermedica’s solutions to operate without requiring FDA clearance for now.
However, under the European Medical Device Regulation (MDR), the same purpose leads to classification as a medical device. This is because the information collected by Infermedica’s solutions can contribute to further diagnosis or patient management, which falls under MDR’s definition of a medical device. Therefore, compliance with European regulatory requirements is mandatory.
Given these regulatory differences, Infermedica has successfully developed and maintained its medical devices under an internal ISO 13485-based quality management system since 2018. The company has also undergone regular audits by
a certification body for this system since 2021.
What's the current status of Infermedica’s solutions in the European Union?
Since 2018, Infermedica’s Triage, Intake, and Call Center Triage modules (legacy device) have been sold as Class I medical devices under the now obsolete Medical Device Directive (MDD). Under a legal transition period approved by the European Commission, these products can continue to be marketed until the end of 2028.
To benefit from this transition period, Infermedica had to align these products with MDR requirements, establish contact with a Notified Body for future certification, and sign a formal agreement for this transition. These steps have been completed, allowing Infermedica to continue providing these modules under the legal framework.
At the same time, Infermedica also offers the Engine API, a critical software component that can serve as the foundation for a medical device. However, the responsibility for final certification lies with the client integrating the API into their product and making it available to end users.
Which Infermedica products will be certified under MDR and when?
Over time, our clients have expressed a strong need for a more integrated solution, combining the functionalities of different modules into a single system. In response, Infermedica has developed a cohesive and streamlined solution, the Medical Guidance Platform (MGP), which merges the capabilities of three separate modules: Triage, Intake, and Follow-up into one unified, interoperable system. Rather than certifying three individual modules under the MDR, Infermedica has taken a more strategic approach by creating one fully integrated medical device. We are currently in the process of certifying MGP as a Class II MDR medical device, and we expect to finalize the process by the end of Q3 2025.
To accommodate different client needs, MGP will be available in two forms:
- iFrame – A ready-to-use solution that can be seamlessly embedded into a system. It comes fully certified, allowing clients to integrate it without additional regulatory burden. Clients can apply their own branding and configuration while benefiting from Infermedica’s MDR compliance.
- Platform API – A set of tools that enables clients to build a custom solution using Infermedica’s components in particular frameworks. However, to maintain MDR certification, the client must strictly follow Infermedica’s implementation guidelines. Additionally, their final product must undergo a full quality check by Infermedica. Upon successful verification, Infermedica will issue a Declaration of Conformity, a regulatory label, and an Instructions for Use (IFU) document specific to the client’s instance of the platform. This process ensures that Infermedica retains regulatory responsibility for the certified solution. Any modifications to the certified implementation must be reviewed and approved by Infermedica.
For clients who prioritize flexibility over MDR certification or are prepared to obtain their own certification, Infermedica will continue to offer the Engine API as a core component. Clients using this solution are fully responsible for determining whether their final product meets the definition of a medical device under applicable regulations. If their product qualifies as a medical device, they must complete the certification process themselves.
In this case, Infermedica’s MDR certification cannot be used to claim regulatory compliance for the client’s solution. We strongly recommend that clients consult with their regulatory advisor to ensure compliance with local medical device regulations.
By offering two distinct approaches, Infermedica ensures that clients can choose the best-fit option, whether they need a fully certified medical device or a customizable framework where they take full regulatory responsibility.
What about countries with close EU cooperation (Switzerland, Turkey, Brazil, and the UK)?
In countries that have close regulatory cooperation with the European Union, such as Switzerland, Turkey, Brazil, and the UK, the status of Infermedica’s products is similar to that in the EU. These countries recognize medical devices in the MDR transition period and accept MDR-certified products at least until 2028. Infermedica has registered their modules in these countries and continuously monitors local regulations in these regions and operates through appointed local Authorized Representatives to ensure ongoing compliance with country-specific requirements.
What is the regulatory status in other countries, such as Australia, Canada, and New Zealand?
Each of these markets has its own medical device regulations, which determine whether a product qualifies as a regulated medical device and the process required for compliance.
Australia (TGA)
In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act. Infermedica is actively assessing the regulatory pathway for its solutions under TGA requirements and exploring potential registration routes. However, clients who wish to fully use the MGP solution must currently conduct the registration process with TGA themselves. This will change once Infermedica obtains MDR certification in Europe, which will allow us to apply for MGP registration in Australia based on our MDR certificate. We plan to initiate this process in late 2025.
Canada (Health Canada)
Health Canada regulates medical devices under the Medical Devices Regulations (SOR/98-282). Based on their intended purpose, Infermedica’s solutions would most likely fall under Class II or III, depending on whether they qualify for any regulatory exemptions. We continue to closely monitor Health Canada’s evolving approach to AI-based medical software, but at this stage, we do not have immediate plans for Canadian certification.
New Zealand (Medsafe)
In New Zealand, medical devices are regulated by Medsafe, with a framework that aligns closely with Australian TGA regulations. While Infermedica’s products do not currently require local certification, we ensure that they meet international quality and safety standards to support potential future market entry.
Infermedica maintains a proactive approach to regulatory compliance in these and other regions. We continuously monitor regulatory changes and adapt our strategy to ensure ongoing compliance with country-specific requirements. Where necessary, we work with local regulatory experts and representatives to facilitate market entry while maintaining the highest standards of quality, safety, and performance.
Future plans
Infermedica is committed to regulatory excellence, aligning our AI-driven solutions with global medical device standards. As we move forward, we are focusing on expanding our MDR-certified portfolio and preparing for additional certifications in key markets such as Australia (TGA) and other regulated regions. Our goal is to develop AI-driven solutions that are not only innovative and intuitive but also meet the highest safety and compliance standards.
By combining symbolic and neural AI approaches, we aim to create a human-like conversational and voice experience that can ultimately achieve medical device certification.
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