How the EU's MDR/IVDR Simplification Proposal Could Reshape Medical Device Software Classification
- Jul 13
- 2 min read
Software is now central to how many digital health products work, and how it is classified under EU law shapes the time, cost and complexity of bringing it to market. A recent article by Timelex, AI4LUNGS' legal partner, examines the European Commission's proposal of 16 December 2025 to simplify Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), and what it could mean for the classification of medical device software.
Under the current rules, most standalone medical device software is classified as Class IIa or higher, which requires a notified body to be involved in the conformity assessment before the product can be placed on the EU market. The proposal's most significant change for digital health is a targeted amendment to Rule 11 of Annex VIII MDR: it would make Class I the default for medical device software, with escalation to higher classes tied to the seriousness of the clinical situation and to how the software's output is used. Where software falls to Class I, the manufacturer could self-declare conformity without involving a notified body. The change concerns software under the MDR; software falling under the IVDR would continue to be classified under separate rules.
The article is careful about the limits of this. Class I is not a shortcut, and the proposal is not a general down-classification: classification still starts from the software's intended purpose, and several key terms in the revised rule remain undefined and will need further guidance.
For projects such as AI4LUNGS, which develops AI tools to support respiratory disease diagnosis and clinical decision-making, these developments matter for designing technologies that are both clinically effective and compliant with the evolving EU framework. Classification also has consequences beyond the MDR and IVDR: for AI-based software, whether the device is subject to notified body involvement bears on its treatment under the EU AI Act.
“Proper classification of medical device software carries significant compliance implications, so this proposal offers genuine hope for a lower-classification pathway. That said, it remains only a proposal at this stage, and manufacturers should keep monitoring the legal framework closely to design their products in a compliant way. ”- Legal expert, Marta Wilinska.
The proposal has not yet been adopted, and the current MDR and IVDR rules remain in force. However, it provides valuable insight into the future direction of medical software regulation in Europe.
The article was authored by the Timelex team Marta Wilińska, Nayana Murali and Vaisakh Shaji.
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