Creating regulated digital health solutions such as Software as a Medical Device (SaMD) is complicated, no matter where you’re doing business. Each region of the world has its own set of regulatory criteria and requirements, with the US and EU being widely recognized as leading regulatory authorities. Even if you feel like you’ve mastered the regulatory framework for the US, what happens when it’s time to expand?
Obviously, this is a complex topic that would take much more than a blog post to fully explore. But for now, let’s consider what biopharma and medtech companies need to know as they launch commercial products beyond the U.S. into the European Union. Here are 3 key points.
The International Medical Device Regulators Forum (IMDRF) defines SaMD as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. “Without being part of” means that the software is not necessary for a hardware medical device to achieve its intended purpose. Here are a few additional important notes:
If your software doesn’t fit the above criteria, it’s not subject to FDA regulations in the US, the EU’s Medical Device Regulation (MDR), or the EU’s In Vitro Diagnostic Regulation (IVDR). But if it does qualify as SaMD, here’s where differences begin to emerge by market.
Related: Software as a Medical Device (SaMD) Solutions
Starting at the surface level, here are two key differences between how the US and EU classify SaMD.
Naming differences aside, the key difference in classification is the process of classifying devices. In the US, a manufacturer classifies its SaMD using previous devices as a guide.
To put it simply: In the US, you classify a device by looking through databases to find an applicable product code and matching device class. If there’s no code, things become a lot harder. When you’re designing a new device and nothing similar has been created before, you have to go through an extensive process with the FDA to get your pre-market approval.
The EU takes a different approach in classifying SaMD. Instead of using prior products as a guide, they use a rules-based framework to classify devices. For in-vitro devices, there are 7 “waterfalling” rules with yes or no questions that lead manufacturers to a classification. MDSW classification is a bit more complex, with 22 rules that must be addressed to get a classification output.
Because manufacturers are able to “self-declare” Class I devices, there’s a common belief that you can bring SaMD to market much sooner in Europe than in the United States. However, several low risk devices have been categorized as “under enforcement discretion” by the FDA, meaning that they are recognized as medical devices, but the FDA chooses not to enforce the regulations at this time because the risk to patients is low. Further, the FDA is working to streamline its regulatory oversight of software-based devices, including piloting a software Precertification (Pre-Cert) Program.
The MDR in the EU came into force on May 26, 2021 with the IVDR coming into force May 26, 2022. Under the MDR and IVDR many software devices have been up-classified, requiring the involvement of a Notified Body, resulting in a 3-6 month review and approval timeline for such devices.
Whether you’re just starting down the path of developing a new device or looking to future-proof (or region-proof) your digital health roadmap, the BrightInsight Platform was purpose-built to help you bring your regulated products to market. Simply put, we handle global regulatory compliance, so you don’t have to. Learn more.