The European Commission has introduced a revision to its guidance on the qualification and classification of software within the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This update, released on June 17, 2025, brings forth several meaningful clarifications without altering the core regulations.
Key Clarifications in Software Classification
A significant addition in the revised guidance is the introduction of the term Medical Device Artificial Intelligence (MDAI), highlighting the EU’s focus on AI-enabled software as a distinct category. This change underscores the regulatory attention on artificial intelligence applications in medical devices, ensuring they meet specific standards under the AI Act. Furthermore, the guidance emphasizes the importance of defining and documenting the intended purpose of each module in modular medical device software (MDSW), reflecting the shift towards multi-modal applications and integrated platforms.
Implications for Medical Device Manufacturers
The enhanced interpretation of Rule 11 indicates that more MDSW may be classified as higher risk, particularly those involved in clinical prognosis or prediction. Manufacturers must reassess their software architectures to ensure each module aligns with regulatory standards and the overall device functionality. Additionally, the reference to the European Health Data Space (EHDS) signifies increased requirements for data portability and structured exchange, impacting those developing electronic health record-related software.
- AI integration in medical devices now subject to distinct regulatory scrutiny.
- Modular software must have clearly defined intended purposes for each component.
- Enhanced Rule 11 broadens the scope of higher-risk classifications.
- Alignment with the European Health Data Space introduces new data handling requirements.
- Additional examples clarify when MDSW without medical intent falls under MDR via Annex XVI.
Manufacturers should revisit their software designs, especially for modular systems, to ensure compliance with the newly clarified guidelines. The expansion of Rule 11 necessitates a thorough reassessment of previously classified software to determine if elevated risk categories apply. Additionally, integrating EHDS standards will be crucial for those handling patient data, requiring updates to technical documentation to meet both MDR/IVDR and EHDS requirements.
The revision to MDCG 2019-11 serves as a pivotal step towards harmonizing the application of MDR and IVDR for medical device software. By explicitly addressing AI and modular designs, the EU reinforces its commitment to ensuring that medical software products are safe, effective, and interoperable with evolving health data systems. Manufacturers equipped with a clear understanding of these guidelines can navigate the regulatory landscape more confidently, fostering innovation while maintaining high standards of patient safety.
This regulatory refinement not only clarifies existing ambiguities but also anticipates future developments in medical software technology. As the industry moves towards more sophisticated AI-driven and modular systems, continuous collaboration between regulators and manufacturers will be essential to adapt to emerging challenges and leverage new opportunities in healthcare technology.
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