MDR Classification Rule 11 for Medical Device Software
The MDR introduces a new classification rule 11. This rule is especially for software. The rule 11 has serious implications: it bears the potential to further undermine Europe's innovation capacity.
EK-Med (expert exchange group consisting of the notified bodies) perceives a stricter classification of software, particularly of apps. The EU commission is even considering revisiting this rule.
What does MDR Rule 11 say?
Rule 11 contains the following provisions:
"Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
- Death or an irreversible deterioration of a person's state of health, in which case it is in class III; or
- Serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software are classified as class I."
Which Software is affected by Rule 11?
First, rule 11 addresses stand-alone software that is a medical device (SaMD). If the software serves diagnostic or therapeutic purposes, it falls under rule 11. You may wonder: Which SaMD does not serve these purposes?
Medical Device Definition
„Any instrument, apparatus, software, etc. intended by the manufacturer to be used for one of the following purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations [...]“
Collating this list with the provision of rule 11, one thing becomes clear:
There will be hardly any stand-alone software left being classified as class I!
(Almost) any software used for the purpose of diagnosis, monitoring, prediction, prognosis or treatment also provides information which is used to take decisions with diagnosis or therapeutic purposes. Exactly this type of software is classified as class IIa or higher under rule 11.
Software that will be classified higher
In general, software will be classified in higher classes. Here are some examples:
|Product||Class according to MDD||Class according to MDR|
|App supporting the selection and dose calculation of cytostatic drugs||I||III|
|Stand-alone software application for AMTS||I||III (depending on the medication)|
|Software suggesting diagnoses based on test results||I||IIb or higher (up to III)|
|PDMS||I or IIa||IIb or III|
|App to diagnose sleep apnoea||I||IIa (or higher)|
|Therapy or radiation planning software||IIb||IIb or III, depending on the argumentation|
Software that might remain in class I
Only the following purposes justify a class I classification:
- Prevention, e.g. a cardio training app offering workout recommendations.
- Monitoring, if not used for diagnosis or if there is no vital threat. E.g. if a software monitors a physiological parameter based on which no diagnosis is proposed and which only indicates non-therapeutic actions. A rather far-fetched example would be software monitoring the fluid balance and reminding to consume fluid.
- Prognosis not intended for decision making.
- Alleviation, e.g. biofeedback systems not considered as therapy since they "solely" easy symptoms.
This article describes another proposal as a way out discussing a separation of data and information. Accordingly, PACS would not provide any information.
What Are the Consequences of Rule 11?
Consequence no. 1: Non-critical applications' costs and expenses explode
As soon as software is no longer classified as class I, manufacturers must
- involve notified bodies
- in general, establish a certified quality management system
Thereby, manufacturers' expenses and costs multiply. Particularly smaller companies such as app developers, start-ups and university spin-offs are highly affected.
Consequence no. 2: The classification does not always mirror the risk
While previously, even highly critical software calculating the dose of cytostatic drugs fell within class I, we can now observe the contrary: Due to rule 11, it could be that even non-critical applications fall within class III.
The reason is that the classification either considers only severity (e.g. "might lead to death") or duration ("irreversible").
- Does every product have to fall within class III, even if product failure results only in highly unlikely cases in death?
- Does each irreversible damage,, however small, require the same classification?
The classification should reflect the risk. Risks are combinations of degrees of severity and probabilities. This is exactly what rule 11 does not take into account.
Software used to calculate dosages of drugs, to select drugs or to schedule therapies such as radiation and surgeries will probably all fall within class III.
Bottom line: Rule 11 will dampen innovation
Patients' safety has first priority. The same goes for patients' health. Rule 11 will impede software development to an extend which makes it hardly possible for small manufacturers to overcome regulatory obstacles.
Products not entering the market will not endanger safety. But products which cannot enter the market cannot contribute to diagnosing diseases and injuries or to alleviating or treating them.
Medical devices can lead to the death of humans. But the same goes for the absence of medical devices. Rule 11's authors will be measured by this.
News Concerning Rule 11 (ex Rule 10a)
Even the EK-Med recognizes the risk for stricter classification: The organization considers this provision, generally speaking, will lead to stricter classification of software, particularly of apps, inter alia resulting in increased involvement of notified body and execution of clinical trials.
The document "EK-MED 1934/16“, also discussing further impacts of the MDR, can be downloaded here.