Thermography Diagnosis System - What class?

P

polish1023

#1
Hi All,
We are developing a thermography device for the early detection of breast cancer. We also provide the user a "diagnosis suggestion" by using our proprietery algorithms to analyze the thermogram.

A thermpograph is classified as a class 1 device according to the meddev. And a similar device on the market has also marked itself as class 1.

However consultants say we are class 2a and should go under examination according to annex 2.
I somehow feel there must be an easier way, at least somewhere in the middle....

Any ideas?

Thanks,
p
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: What class? Thermography Diagnosis system -

Hi All,
We are developing a thermography device for the early detection of breast cancer. We also provide the user a "diagnosis suggestion" by using our proprietery algorithms to analyze the thermogram.

A thermpograph is classified as a class 1 device according to the meddev. And a similar device on the market has also marked itself as class 1.

However consultants say we are class 2a and should go under examination according to annex 2.
I somehow feel there must be an easier way, at least somewhere in the middle....

Any ideas?

Thanks,
p
Hi "P" and welcome to the cove :bigwave:

Look, it's quite simple... All you have to do is take the Medical device Directive to hand and apply the classification rules on annex IX. If you come up with class I, and some consultant says it should be class IIa, just ask them what rule did they apply to come up with that conclusion. Then you can either accept their rationale or argue against it, but at least you are conducting an educated discussion...

By the way, from the sound of it I understand that even if this is a class 1 device it would still come under "class 1 with a measuring function", which calls for some extra steps, relative to the plain class 1. Just follow the MDD or look for the relevant guidance documents (MEDDEV's, NB-MED's etc.).

Best of luck,
Ronen.
 
P

polish1023

#3
Thanks for the prompt reply, "R". I have reviewed annex 9 according to your suggestion. I have yet another question:
We provide users the differences in skin surface temperature (rather than the temp itself) and using our algorithms we provide a diagnosis regarding the patients breast health.
Are we considered "intended to allow direct diagnosis or monitoring of vital physiological processes"?

That is = is skin surface temp difference a VITAL PHYSIOLOGICAL PROCESS?

Regarding being class 1M
Our device does not provide measurement of body temp. but rather temp. differences (differences in skin surface temperature). So we don't claim that and we don't put temp. units anywhere (as we measure diff).

Thanks for your help,
P


 

Ajit Basrur

Staff member
Admin
#4
Agree with Ronen - its still a Class I device. Refer Page 35 of http :// ec .europa.eu/enterprise/sectors/medical-devices/files/meddev/2_2_4-1part2_07-2001_en.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS
 
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