Is internally used diagnostic software considered a medical device under MDR?

Question

Our company has developed three software components related to EEG and ECG biomarkers to support psychiatric treatment decisions:
• A web interface for hospitals and clinics to upload and store patient data (e.g., sex, age, EEG).
• An internal biomarker calculation pipeline, used only within our company, that processes EEG/ECG data and outputs biomarkers.
• A PDF report presenting the biomarker results to psychiatrists, used to inform therapeutic decisions.

Given that the biomarker calculation and reporting software are not placed on the market but are used to provide a service, are these considered Software as a Medical Device (SaMD) under the MDR? Additionally, are we considered medical device manufacturers if we only use this software internally? To what extent does the web interface need to be covered by the QMS?

Dr. Oliver Eidel · Accepted Answer

Yes, your software would be considered Software as a Medical Device (SaMD) under the MDR. Even if you are not placing the software itself on the market, you are providing a service (the analysis and resulting reports) that is made available to healthcare professionals for clinical decision-making. This is generally interpreted as 'making available on the market' under MDR definitions, so you would be considered a medical device manufacturer.
For the web interface, if it is part of the workflow and connected to the SaMD (e.g., used to collect the data that feeds into the biomarker calculation and reports), then it should be included in the scope of your QMS to ensure end-to-end traceability, risk management, and compliance.
I suggest reviewing Article 6 of the MDR, as well as the definitions and guidance in MDCG 2019-11 and the IMDRF SaMD documents. Also, the Blue Guide offers helpful explanations about 'placing on the market' and 'making available on the market.'

Answer

You should also consider whether any of your software components might be classified as an accessory according to MDR Article 2(2). Accessories are also considered medical devices if they are intended to enable or assist the medical functionality of another device. However, it's not always clear-cut for software, and the guidance is limited here. Accessories are typically class I, so if your web interface or other tools fall into this category, they would also need to be addressed under your QMS.

Is internally used diagnostic software considered a medical device under MDR?

2 Answers

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