MDR Rule 10 interpretation - Active Device

[piccoto]

Hi everyone,
I'd appreciate your interpretation of Rule 10.
Is ANY active device intended for diagnosis and monitoring should be classified as class IIa, or is it only if the device is BOTH active device intended for diagnosis and monitoring AND either one of the "if" sections?

Do we read it with full stop after the first sentence :
Active devices intended for diagnosis and monitoring are classified as class IIa ?

This is the rule as appears in the MDR -

Rule 10 -
Active devices intended for diagnosis and monitoring are classified as class IIa:
— if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I;
— if they are intended to image in vivo distribution of radiopharmaceuticals; or
— if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.

Thanks

 

[Tidge]

I'm aware of devices which (in the past) almost certainly should have been classified as Class IIb, but were self-identified by the manufacturer as Class IIa... and the NB of the time accepted them as class IIa, and that classification has been used ever since. I can try to offer an explanation about why a IIa classification stands as a sort of superset of IIb without much questioning:

The devices I am thinking of are providing indicative information about a patient status as opposed to decisive information. This line between providing indicative and decisive information is a little blurry for multiple reasons, including:

• Certain users will immediately look at a particular patient parameter and immediately make a diagnosis without recognizing that the device itself isn't making the diagnosis but instead that the user is making the diagnosis.
• Manufacturer's often make serious (marketing) claims about how a certain device is improving patient outcomes because of the way that device contributes to diagnoses. Sometimes this form of 'exaggeration' leads (backs?) a company into a higher classification.

I recall a 2012 COCIR recommendation to add a definition for "direct diagnosis":

"A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition by itself or when it provides decisive information for the diagnosis.”
​

This was not adopted but I think this definition offers some clarity, especially on the first bullet point above.

 

[piccoto]

Thank you so much, it really answered my question!

 

[Ronen E]

Is ANY active device intended for diagnosis and monitoring should be classified as class IIa, or is it only if the device is BOTH active device intended for diagnosis and monitoring AND either one of the "if" sections?

Neither.

IIa is the default classification for active devices intended for diagnosis and monitoring.

The rule lists several exceptions:
- If they're only intended to illuminate the patient's body, in the visible spectrum, they're class I.
- if they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, they're class IIb.
- If they're intended to emit ionizing radiation for diagnostic radiology, they're class IIb.

Note: For a device to be "intended for diagnosis and monitoring" it doesn't have to provide the diagnosis or information decisive in making the diagnosis. It merely needs to be intended to provide information contributing towards diagnosis and monitoring, i.e. informing the user about the patient's state (for "monitoring" - in real time).

 

[the_norwegian]

Hi,

First post on this excellent forum.

I have a specific question related to rule 10 and ECG devices. Would ECG devices in general be considered to be class IIb under rule 10? I have noticed several blog posts on MDR rule 10 referring to ECG as an example of a class IIa device. Am I misinterpreting rule 10? Or are the producers of ECG devices formulating their intended use statement such that they are avoiding the class IIb? Or are the blogs claiming that ECG equipment is class IIa wrong?

 

[dgrainger]

Take a look at MEDDEV 2. 4/1 Rev. 9 - DocsRoom - European Commission
P42 & 43 look at Rule 10, of note is:

Examples of special concepts:​

Note 1: Vital physiological processes and parameters include, for example respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care are in Class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals in routine check ups and in self-monitoring are in Class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a temperature measuring device.​

It would therefore depend on your use case.

 

[the_norwegian]

Thanks for your response. MEDDEV 2.4/1 Rev. 9 was issued in 2010 and refers to MDD, so therefore I was not sure if it was still relevant. I now understand that it is.