Classification of product (measuring or not?)

#1
Hey Elsmar Cove, hoping someone here could help me shed a bit of light on my issue.

We're manufacturing hospital beds in North America, but we're soon wanting to market in the UK market along with Europe eventually.

Now, my dilemma comes from whether or not our product is classified as having a "measuring function". We have a scale on our beds, but strictly for reference only, as indicated in our user's manual. It is not intended to be used for dosage or medical treatment.

MEDDEX 2.1/5 is a guideline pointing me towards that we do not have a "measuring function" since criteria A (it is not intended to measure a parameter) and C (accuracy can't lead to adverse effect on the patient, since it's stated to be used as a reference only) are not met.

2017/745 section 6.2 (f) wouldn't be applicable since it does not have a "measuring function"
2017/745 section 7 (b) would also not be applicable for the same reason
93/42/EEC section 10 (with sub sections 10.1 and 10.2)

Am I right for thinking that our product does NOT have a measuring function based on the documentation available?

EDIT : just realized there's a better sub-forum for this, if a mod would move it there it would be greatly appreciated, thanks in advance.
 
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mboynton

Starting to get Involved
#2
Hi SLandry92,

I agree with your approach of consulting the criteria defined in MEDDEV 2.1/5.

If I understand your description of the bed (if by scale you mean a scale for weighing the patient in the bed), then I think that the scale may very meet criteria a) under the MEDDEV since patient weight can be considered a physiological parameter.

I think it is plausible that you may determine criteria c) does not apply. However, note that the MEDDEV 2.1/5 considers commonly understood use as well as the manufacturer's accompanying documentation.

"The expression « claimed implicitly » covers cases where the user, on the basis of the designation of the device or of its accompanying documents, or on the basis of the common use is entitled to expect accuracy where the accuracy of the measurement has an impact on the diagnosis or therapy of the patient."

Based on this, you may need to argue further why a physician considering the patient weight displayed by the scale as an input to a therapeutic response/ treatment decision should not be part of the common use/ expected use implicit for the scale. It could help to define in the technical file what other non-measuring purpose the scale does serve - if the weight value is "for reference only", then for what is it referred to, other than determining treatment?

On a separate point, you may also like to take a look at 2014/31/EU or 2014/32/EU on weighing instruments, too.
 

dwperron

Trusted Information Resource
#3
Now, my dilemma comes from whether or not our product is classified as having a "measuring function". We have a scale on our beds, but strictly for reference only, as indicated in our user's manual. It is not intended to be used for dosage or medical treatment.


I'm sorry, but if I bought a bed with a scale built in I am going to assume that it has a measuring function, and reasonably expect a level of accuracy commensurate with the task. Why else would you build a scale into a bed?
I would like to see how easy it is to find the disclaimer in your manual. I bet it doesn't mention that the scale is "for reference only" in your advertisements...
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#5
You wont be able to ignore the scale. It has performance criteria and will likely need regulations.
 
#6
You wont be able to ignore the scale. It has performance criteria and will likely need regulations.
Exactly what I figured too, you guys just indirectly confirmed that we shouldn't have a reference only type mention in the user's manual and it was exactly what I was looking for!
 
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