The EU and US terminology systems for medical device software both use the core definitions published by the International Medical Device Regulators Forum (IMDRF) in 2013 as their global baseline, but each has developed its own terminology, scope relationships and usage conventions based on its regulatory framework.
EU MDSW (Medical Device Software):
US SaMD (Software as a Medical Device):
2. How the terms differ
The scope of the EU’s MDSW is much broader overall than SaMD as defined by the International Medical Device Regulators Forum (IMDRF):
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(1) It covers standalone medical software + embedded medical software + IVD medical software.
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(2) Diagnostic/therapeutic software starts at Class IIa at minimum; the vast majority requires notified body review, with no general exemptions.
The US SaMD fully matches the official IMDRF definition:
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It covers only medical software that runs independently and does not depend on hardware.
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Three-tier risk classification; low-risk products can be exempt from pre-market review, so the compliance threshold is lower.
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IMDRF general definition: SaMD is software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device. Its regulatory status does not depend on where it physically runs (e.g. in the cloud or on a hardware computing platform). If the software is necessary for a hardware medical device to achieve its medical purpose, it is not SaMD but a component of that hardware.
3. Notes on using the terms
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In everyday industry communication, MDSW and SaMD can be used interchangeably when referring only to “medical software that runs independently of hardware”. For EU market compliance submissions, technical documentation and communication with notified bodies, the term MDSW must be used; in the US and in global regulatory contexts, SaMD is used.
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Never include “embedded medical software” in the scope of SaMD – although it clearly falls within the statutory scope of EU MDSW. The key boundary test is whether the software is a necessary component for a hardware medical device to achieve its intended medical purpose.
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The EU definition of MDSW is directly tied to demanding classification and review rules, whereas the US definition of SaMD only defines the regulatory boundary, with differentiated requirements then applied through risk classification. For the same standalone medical software, the compliance cost and review difficulty of an EU MDSW submission are generally far higher than for a US SaMD submission.
Future directions in medical software regulation:
The FDA launched the Software Precertification (Pre-Cert) Program, shifting the regulatory focus from “the product itself” to “the product developer” by assessing a company’s quality culture, patient safety awareness and cybersecurity responsibility. It simplifies or exempts pre-market review for low-risk products and uses real-world performance data to support regulation. The programme is currently piloted only for SaMD.
Focus on the regulatory challenges of artificial intelligence (AI) / machine learning (ML) SaMD
AI/ML SaMD can self-learn and adapt, and its iterative updates during operation pose new challenges for conformity assessment. The IMDRF is still developing further guidance; the FDA has published related discussion papers and proposes the Pre-Cert Program as the regulatory route for such software.
Industry trend: innovation in medical devices is booming and software has become one of the core drivers of medical devices. Global regulation will increasingly seek a balance between “encouraging innovation” and “ensuring safety and compliance”.
Conclusion
This series of educational articles introduces FDA, NMPA, GMP, CE MDR/IVDR and MDSAP regulations and standards.
EVERBIZ is happy to share medical device expertise with industry clients, and hopes our extensive practical experience in quality systems and product registration will be helpful.
Let’s contribute together to the development of the medical device industry – if you have any questions or needs, please contact us.
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
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