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MDR 2017/745 Classification Guide

#1
I'm starting this thread to discuss the classification of different medical devices according to MDR 2017/745. In this regard, I request experts to give their views

So, being the first can someone guide me about classification rule and class of laryngoscope as per MDD and MDR.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
I'm starting this thread to discuss the classification of different medical devices according to MDR 2017/745. In this regard, I request experts to give their views

So, being the first can someone guide me about classification rule and class of laryngoscope as per MDD and MDR.
Did you give it a go?
What's your outcome?
If you got stuck - where/why?
 

Watchcat

Posts Moderated
#3
I'll sort of second RonenE on this one, by saying that you will probably get a better result if you first work through the classification rules yourself. Then, if you find something that seems ambiguous with respect to classifying your device, describe that ambiguity to the forum. As an example, see the recently lengthy discussion on Rule 11 in the sub-forum on EU device regulations.

My second suggestion is that, because MDR 217/745 is a regulation instead of a standard, you might get a bit better response if your post was in that sub-forum than in this one. (RonenE, what do you think?)
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
My second suggestion is that, because MDR 217/745 is a regulation instead of a standard, you might get a bit better response if your post was in that sub-forum than in this one. (RonenE, what do you think?)
Thanks, I moved the thread to the "right" forum.
Ronen.
 
#5
I'll sort of second RonenE on this one, by saying that you will probably get a better result if you first work through the classification rules yourself. Then, if you find something that seems ambiguous with respect to classifying your device, describe that ambiguity to the forum. As an example, see the recently lengthy discussion on Rule 11 in the sub-forum on EU device regulations.

My second suggestion is that, because MDR 217/745 is a regulation instead of a standard, you might get a bit better response if your post was in that sub-forum than in this one. (RonenE, what do you think?)
Thanks for guiding me, As I am new on this forum so couldn't differentiate the forum to put it in the right thread. I have studied the rules so the confusion is that Laryngoscope consists of two parts one is the handle containing a battery (which surely is active) but the other one that is laryngoscope blade that just depresses the tongue and illuminates the light either through optical fiber or through bulb (whichever is installed with blade). Firstly, I want to know that can I classify these two parts as one. If yes then under which rule.
Rule 5 class I if we consider this non-active as whole or Rule 10 clause 1[except for devices intended to illuminate the patient's body, in the visible spectrum, in which case they are classified as class I].
 

twanmul

Starting to get Involved
#7
I think you're getting tied up here on whether it is active or not based on the handle.
In reality, your device is active irrespective of the handle as the light (which is encompassed in the blade) relies on an energy source external to the body. You could classify the battery separately as an accessory but in reality you're best combining the classification.
You're also getting tied up in what single rule to apply. I think both of your quoted rules apply as your device is both an invasive device of the oral cavity and is active.
You should therefore classify this using both rule 5 and rule 10.
Under rule 5, if the device is only intended to be used in the oral cavity as far as the pharynx, then it is Class I (Class IIa if further).
Under rule 10, if the device is intended to illuminate the patient's body in the visible spectrum, then it is also Class I.
These rules aren't mutually exclusive and you can combine them, taking the highest risk classification. In this case, they are the same risk classification and so Class I applies. If the device is used further than the pharynx, then the higher risk classification of Rule 5 would apply and Class IIa would be the result.
 
#8
I think you're getting tied up here on whether it is active or not based on the handle.
In reality, your device is active irrespective of the handle as the light (which is encompassed in the blade) relies on an energy source external to the body. You could classify the battery separately as an accessory but in reality you're best combining the classification.
You're also getting tied up in what single rule to apply. I think both of your quoted rules apply as your device is both an invasive device of the oral cavity and is active.
You should therefore classify this using both rule 5 and rule 10.
Under rule 5, if the device is only intended to be used in the oral cavity as far as the pharynx, then it is Class I (Class IIa if further).
Under rule 10, if the device is intended to illuminate the patient's body in the visible spectrum, then it is also Class I.
These rules aren't mutually exclusive and you can combine them, taking the highest risk classification. In this case, they are the same risk classification and so Class I applies. If the device is used further than the pharynx, then the higher risk classification of Rule 5 would apply and Class IIa would be the result.
Thanks for your reply. all I got is that we have to mention risk class like Class-I is for our case, there is no concern whether we mention this in rule 10 or 5 as risk analysis would be the same?
I was thinking, If we mention this in rule 10, we would be classifying this as active so is there any special requirement in that scenario?
 
#9
Don't forget the 3rd clause of rule 10 as the you may be claiming that the laryngoscope is 'intended to allow direct diagnosis' = IIa or 'intended for diagnosis in clinical situations where the patient is in immediate danger' = IIb.

Direct diagnosis is now defined:

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

There is an argument now that a laryngoscope should be class IIb under this updated rule!
 
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