Clarification on MDCG 2019-11 Revision (June 2025) – Impact on Modular MDSW Marking

[mjazouli]

Hello,


In June 2025, a new revision of MDCG 2019-11 was released, further elaborating on the constraints related to MDR marking of modular software.


In previous years, we have observed that some manufacturers have been placing MDR marks (e.g., as Class IIa SaMD) on backend or API-only modules that contain key medical algorithms, while deliberately excluding the frontend components (input/output interfaces) from the scope.


This approach allowed these companies to sell the MDR-marked “SaMD product” to multiple integrators who, in turn, did not need to undergo any MDR conformity assessment, since data input, storage, and display functionalities are generally not considered medical devices.


The new guidelines add clarification under point #7, stating:

“...
a manufacturer develops an MDSW extension that operates through the user interface of a host module or platform that itself does not meet the definition of a medical device. Even though the host module is not regulated under Medical Devices Regulations, the MDSW relies on its interface for user interaction. Therefore, the manufacturer must assess the host module’s interface as part of the MDSW's usability and clinical performance evaluations.


Accordingly, manufacturers must clearly define and document the boundaries and interdependencies of each module. A comprehensive safety and performance assessment of the MDSW, including relevant non-medical functionalities should be conducted. To ensure appropriate use and regulatory compliance, manufacturers must provide users with clear information regarding the scope, regulatory status and coverage of each module.”

My question:
Do you believe these new requirements will, in effect, oblige software manufacturers to include the frontend within their technical documentation, usability, and performance evaluations — thereby preventing external companies from using these modules with their own frontends unless such integrations are MDR-marked with a classification equivalent to the core module?

Has any of your already got word on the Notified body position on new and more importantly already marked devices?

thank you in advance for any help

 

[dgrainger]

The regulations apply to the finished product so if used in combination with other software/hardware, it would include all aspects including the frontend to be assessed to meet the GSPRs e.g. 14.1.