What AI documentation should not do: no diagnosis, no ICD codes, and where the MDR line runs
Whether a tool for the practice falls under the EU Medical Device Regulation is decided by its intended purpose — and under Art. 2(12) MDR that follows not only from labelling and instructions for use but expressly from promotional and sales material as well. A tool that writes down and orders a conversation stays documentation. One whose output is meant to prepare a medical decision is classified under Annex VIII, Rule 11. This page explains where the line runs, why it is written on every product page, and what a practice should know about it before a pilot.
Reviewed editorially against product behaviour and the stated primary sources; not individual medical or legal advice.
This overview is general information and not legal advice. Every practice has to check the legal basis, the information given, the consent process and its data protection measures for its own use with its legal or data protection advice.
Intended purpose is created on the product page too
Art. 2(12) MDR defines intended purpose as the use for which a device is intended according to the manufacturer's data — and expressly names three places: the label, the instructions for use, and promotional or sales material. A sentence on a product page is therefore not a marketing question but a building block of the regulatory classification.
That is why serious vendors in this market are so conspicuously restrained in how they describe things — and why an advertising promise can lift a product into a class it was never built for. The software does not change; the intended purpose does.
Art. 7 MDR sharpens this further: labelling, instructions for use and advertising may carry no statements that mislead about intended purpose, safety or performance — in particular by ascribing functions to the device that it does not have. Both directions are forbidden: promising too much and reassuring falsely.
What Art. 2(1) MDR lists as a medical purpose
The definition names a list of purposes, and if a manufacturer claims one of them for its software, that software is a medical device. In substance the list covers: the recognition, prevention, monitoring, prediction and prognosis of disease, its treatment or alleviation, the same for injury and disability, and the investigation, replacement or modification of anatomical or physiological processes.
We render the list in substance here rather than word for word, and that is itself an example of the rule this page is about: the official text is under the sources and is the version that counts.
The decisive word is "intended". It is not about what a program could technically do, but about what the manufacturer declares it for. Two tools with the same model underneath can sit on different sides of this line because their vendors say different things about them.
Rule 11: where software becomes class IIa
Annex VIII of the MDR contains the classification rules, and Rule 11 is the one for software. It places software that provides information used to take decisions about recognition or treatment in class IIa as a matter of principle.
Upwards it gets stricter: class III where such decisions may cause death or an irreversible deterioration; class IIb where they may cause a serious deterioration or a surgical intervention. Software for monitoring physiological processes is otherwise class IIa, and all other software class I.
For a practice that means one thing above all: a tool whose output is offered as a basis for decisions needs a conformity assessment and carries a CE marking as a medical device. If that is missing and the output is nonetheless advertised that way, this is not a detail but the heart of the problem.
MDCG 2019-11 and the question that decides it
In October 2019 the Medical Device Coordination Group published MDCG 2019-11, its guidance on the qualification and classification of software. It is not binding, but notified bodies and authorities draw on it, and it runs the check in a few steps.
- Is the product software within the meaning of the guidance at all?
- Is it an accessory to a medical device, or does it drive one?
- Does it perform an action on data that goes beyond storage, archival, communication and simple search?
- Is that for the benefit of an individual patient — and not for aggregated data or general literature?
There is no express exemption for writing things down
This is the honest part of this page. Neither the MDR nor MDCG 2019-11 names "software that only records, transcribes and orders" as an exemption of its own. The guidance lists simple search and general tasks such as word processing, data transfer or backups as non-qualifying examples; writing down a conversation is not among them.
So anyone claiming a documentation tool is "by definition not a medical device" is saying more than the texts do. The defensible statement is a different one: classification follows the declared intended purpose, and a tool that exclusively reproduces and orders claims none of the medical purposes listed in Art. 2(1).
That is exactly why the language on a product page is not decoration. It is the declaration the classification hangs on — and it is the only thing a practice can read before buying.
What KiPT Voice therefore does not do
The sentences below are not modesty and not positioning. They are the intended purpose, and they are on every one of our pages in the same words for that reason.
- KiPT Voice makes no diagnosis.
- It suggests no differential diagnoses.
- It assigns no ICD codes and no fee schedule numbers.
- It performs no triage and grades no severity.
- It offers no treatment recommendation.
- It structures what was said, for review by the treating person — nothing more.
What a practice can check on a vendor page
You do not have to have read the MDR to see the line on a product page. Five questions are enough, and all five can be answered on screen.
- Does the page promise more than a reproduction and ordering of what was said?
- Are there formulations that ascribe a medical judgement of its own to the tool?
- Is a CE marking as a medical device shown — and if so, for which class and from which notified body?
- Does it say anywhere what the tool is expressly not intended for? That statement is conspicuously often missing.
- Do the product page, the instructions for use and the contract agree, or does the page promise more than the document?
How this relates to the AI Act
The two frameworks interlock without replacing each other. Art. 6(1) of the AI Act ties classification as a high-risk system to products under its Annex I, and that annex names the Medical Device Regulation. A tool that is not a medical device does not become a high-risk system by that route either.
Conversely, the AI Act does not turn a documentation tool into a medical device. It adds obligations of its own, first among them AI literacy under Art. 4, and leaves the question of intended purpose where it belongs: in the MDR.
Frequently asked questions
Is a documentation tool automatically not a medical device?
No. There is no exemption that attaches to the kind of tool. Classification follows the intended purpose under Art. 2(12) MDR, and the manufacturer declares that — among other places, in its advertising. A tool that exclusively reproduces and orders claims none of the medical purposes in Art. 2(1).
Why does this page say so often what the product does not do?
Because that is the intended purpose. Under Art. 2(12) MDR promotional material counts towards it, and Art. 7 MDR forbids misleading statements in both directions. A line that holds only internally and is not on the product page is not a line.
What does Rule 11 mean for a tool that makes suggestions to me?
Where the output is offered as a basis for decisions about recognition or treatment, Rule 11 applies and the software is at least class IIa, with a conformity assessment and a CE marking. A draft a physician reviews and takes responsibility for is something other than a recommendation she is meant to follow.
How do I spot a problem on a vendor page?
By promises that go beyond reproducing and ordering, without a CE marking as a medical device and a notified body being named. And by there being nothing anywhere about what the tool is expressly not intended for.
Is this legal advice?
No. This page renders the cited provisions in substance and links the official texts. Whether a particular product is a medical device is decided by the manufacturer with its conformity assessment, and in a dispute by the competent authority — not by a knowledge page.