Short answer: In the EU, software is a medical device when its manufacturer intends it to be used for a medical purpose, such as diagnosing, preventing, monitoring, predicting, treating or alleviating disease, as defined in the Medical Device Regulation (EU) 2017/745 (MDR), which applies since May 2021. Software that only records, stores, organises or transmits data, or supports general wellness, is usually not a device. Intended purpose, as stated in the labelling, instructions and marketing, is what decides.
How Rule 11 classifies software
When software is a device, MDR Annex VIII Rule 11 sets its risk class:
- software that provides information used to take decisions for diagnosis or therapy is at least class IIa, and IIb or III if those decisions could cause serious deterioration or death;
- software intended to monitor physiological processes is class IIa (IIb for vital parameters where variations could result in immediate danger);
- all other software is class I.
Class IIa and above need a notified body. The guidance document MDCG 2019-11 explains qualification and classification with examples.
Where the line usually falls
- A personal health record that stores your results, letters and symptoms, and lets you share them: generally not a device.
- An app that tells you whether a symptom pattern means a specific disease, or suggests a dose: very likely a device.
- Wording matters: "tracks and shows trends for your doctor" describes record keeping; "detects" or "diagnoses" describes a medical purpose.
The US FDA uses a related but different framework (software as a medical device, clinical decision support guidance).
In Anpheros
Anpheros Daily is designed as a record: it records, organises and shows trends and similarities, and it does not diagnose or recommend medicines. That is why every Anpheros page and summary ends with what it does not do. See our guide on symptom checkers vs symptom trackers.
Related pages
- How accurate are smartwatch health measurements? Heart rate, SpO2, sleep and ECG
- EHR vs EMR vs PHR
- Software as a medical device
- MDR vs IVDR
- Health data regulation map
Sources
- European Commission: Medical devices, new regulations
- EMA: Medical devices
- European Commission: MDCG guidance, including MDCG 2019-11, Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745
Frequently asked questions
When is software a medical device in the EU?
When its intended purpose, as stated by the manufacturer, is medical, such as diagnosis, monitoring or treatment decisions.
What is MDR Rule 11?
The rule in Annex VIII of the MDR that classifies medical device software, mostly into class IIa or higher when it informs diagnosis or therapy.
Is a symptom tracker a medical device?
Usually not, if it only records and shows data. A symptom checker that suggests diagnoses usually is.
Does wording in marketing matter?
Yes. Intended purpose is judged from labelling, instructions and promotional material.
Try it free in the sandbox
Your first FHIR call in 5 minutes. An HL7 FHIR R4 API with the patient's consent built in: try it in the sandbox, then connect your own app or clinic system.
Free · 30 synthetic patients · no card
Anpheros builds a medical record that the patient controls and can share with any clinic, on an HL7 FHIR R4 platform, based in the EU. These guides help you understand and organise your health; they do not replace your doctor.
About Anpheros →
AnpherosThe more you log, the clearer your record
Your health history in one place, under your control.
Free · Works in your browser · No card
