Part 2: Non-Invasive Devices
Definition of Non-Invasive devices
Unfortunately the MDR does not contain any definition of “non-invasive”. The only way to assess if the device in question is “non-invasive” will be to rule out every possibility that the device could be either an active device or an invasive device or a special device.
It is important that this evaluation is documented in full extend. The documentation of the decision will need to be provided to the notified body or competent authority one day.
Step 1: Rule out “active devices”
According to Chapter 1, Article 2, number (4) ‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy.
But ‘devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active device’ which means for example a tube for transporting liquid from a drip to a patient is not an active device. Also an optic fiber that transmits laser light to the patient is not to be regarded as an active device.
Step 2: Rule out “invasive devices”
According to Chapter 1, Article 2,number 6
an invasive device is defined as ‘any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body’.
Here we have four decisions:
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Is the device as a whole intended to penetrate inside the body through a body orifice?
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Is the device as a whole intended to penetrate inside the body through the surface of the body?
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Is a part of the device intended to penetrate inside the body through a body orifice?
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Is a part of the device intended to penetrate inside the body through the surface of the body?
It seems to be trivial to split the original definition into four questions. But it is very effective. If you answer them all and document the answers you are sure not to forget any aspect and discussions with an auditor are avoided.
If any one of these questions is answered with “yes” you do not have a non-invasive device!
Step 3: Rule out “special devices”
There are rule 14 through rule 22 which consist of several sub rules and constellations where even if the device would be a non-invasive device from the above evaluation it still has its own classification and will not be classified under the rules of non-invasive devices.
During the course of ruling out “special devices” it is necessary to go through all these rules. This process is a bit complex and I will cover this in the next part of this “How-To”. The true added value of evaluating the rules 14 through 22 is in the finding of your device having a “yes”.
As soon as you assign a “yes” to on one of these rules you will be done immediately with classification.
At Orange-Moon we are preparing a specialized tool to make this process very easy. Currently the tool is not available – please check back 30th November 2019.
Conclusion:
Non-Invasive = Ruled out special device + ruled out invasive device + ruled out active device
You are sure now that you are classifying a non-invasive device. I found the order of the rules not to be very logic so I recommend starting with rule 4 and in particular the last sentence of the rule:
“This rule applies also to the invasive devices that come into contact with injured mucous membrane.“
Wait – aren‘t we talking about non-invasive devices? Right! So a rule for non-invasive devices also applies for some invasive devices. Well we will see in a later part of this How-To if and how this rule is also listed in the rules for invasive devices.
The classification assessment for non-invasive devices is done fairly easy if you start out in reverse order starting with rule 4. Why in reverse order? The structure of the MDR requires that neither rule 4 nor rule 3 nor rule 2 apply before rule 1 applies which then results having a non-in