MDD Classification of Software which Supports Physicians - Premie Nutrician

N

nyholm

#1
I am a newbie in this area and have now run into my first problem. I need to classify a software which is used for supporting the physicians when deciding the amount of different nutrition’s for premature babies. How should I think? A malfunction in the application would be really serious for the babies, but is it a medical device? At the bottom line we are talking about deciding amounts of food.

Besides: I want to thank all contributors for this wonderful forum. I have never seen anything better. :truce:

Regards
 
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Marcelo

Inactive Registered Visitor
#2
Re: MDD classification of software

It does seem to fall under the definition of medical device of the MDD. I think you should think about a device which has a "similar" function (and the similarities in this case would be very superfluous, i think) and use the same risk classification.

Have you contacted your - or a - notified body?

Sorry for not helping much - todays it´s post-carnival in Brazil, and i´m still a little dizzy :)
 
M

madannc

#3
Re: MDD classification of software

I am a newbie in this area and have now run into my first problem. I need to classify a software which is used for supporting the physicians when deciding the amount of different nutrition’s for premature babies. How should I think? A malfunction in the application would be really serious for the babies, but is it a medical device? At the bottom line we are talking about deciding amounts of food.

Regards
Hi nyholm,

it is not so much about the what the software does but more about its application/intended use, take for instance a data export program used within a photoshop application clearly this would not fall under 13485 and the risk associated with this would be based upon losing a pictorial representation (loss of a photo), however if the same application was used for transerring data sets when imaging on a linear accellerator for registration prior to treatment then its application is for medical purposes and the consequences of getting it wrong are much higher, thus the verification, validation and risk analysis are much higher. In the instance given DICOM std (Digital Imaging and Communications in Medicine) would also apply. In short software used within medical devices are subject to more vigorous testing.

You may want to look at IEC 62304 - Medical device software - Software life cycle processes.

IMHO the software would fall under medical device if installed and used for the purpose you described.

Cheers Nigel

PS welcome to the Cove
 
R

Roland Cooke

#4
Re: MDD classification of software

I would recommend getting a formal decision from the Competent Authority, either directly, or via your Notified Body. If you don't have a Notified Body yet, we can help :D :cool:, what I would do is take full details of your software/clinical application and
a) check with my software experts (maybe they already know the answer)
b) request a formal response from my Competent Authority. (The UK MHRA is actually very good with these requests, responding within a maximum of four weeks, and often much faster).
 
N

nyholm

#5
Re: MDD classification of software

Thank you very much for your advice. My personal feeling is that this should be handled as a medical device.

mmantunes: Is "similar" to a medical device something which is mentioned in any standard?

Roland Cooke: We are in the process of deciding upon which notified body to use. I will have you in mind. :)
 

Marcelo

Inactive Registered Visitor
#6
Re: MDD classification of software

Hello Nyholm

No, it´s not mentioned in any standard. What i tried to say is, try to find a medical device which has some principle of operation or principle of use which can be correlated in some way to your device. For example, as your device gives support to decision making about a health condition, it can be related to a diagnostic device. Improbable as it may seem, it looks a lot like some radiological diagnostic equipment which diagnoses a condition and gives support to the doc to make a decision.

The problem with this exampl e is that the risk classification of radiologic device is high because of the radiation, not because of the hazard of incorrect output to decision making. So try to find a device in which the hazard is mainly because of the decision-making hazard and use the dsame risk classification.
 
W

wrodnigg

#7
nyholm,

Take a look at the Notified Body Association site and especially at the TEAM-NB Recommandations.

There you find recommendation NB-MED/2.2/Rec4 especially on Software and Medical Devices, where many examples are given, which software is classified as MD and which is not.

The final decision is up to a competent authority, and yes, to my opinion, your intended purpose points to a classification as a medical device, either by
...intended for the analysis of patient data generated by a medical device with a view to diagnosis and monitoring
or by
...intended for use for/by patients to diagnose or treat a physical or mental condition or disease
 
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