Software medical device labelling

V

vbosq

Hello,

I try to find what info is mandatory on the label of software as a medical device/accesory to a medical device. What are the reguirements for EU and FDA?
 

shimonv

Trusted Information Resource
Have a look at:
ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements. This standard is recognized by the EU and FDA.

EN 1041:2008
Information supplied by the manufacturer of medical devices
This standard is applicable to the EU market.

You can also look at labels for similar products online.

Goodluck,
Shimon
 

akp060

Involved In Discussions
Hi,
there is one earlier GHTF report on labeling that I would propose:
http://www.imdrf.org/docs/ghtf/fina...el-instruction-use-medical-devices-110916.pdf

There are also requirements for UDI (Unique Device Identification) to look into.

Software does not really differ for labellig from non-software devices.

Hope this helps
Regards
Szabolcs

Hi,
I was viewing this post while seeking somewhat related answers.

Would like to identify that N70 is superseded by N52, link below, hope it helps members who would view this thread in future
http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-labeling-md-ivd-n52-180712.pdf

T.Y.
 

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akp060

Involved In Discussions
Adding to what has been said by respected members above, the requirements of EU are covered in BS EN 1041:2008+A1:2013 , and that of FDA in
21 CFR 807.87 (e) . Now the interpretation of these are very simple (please read N52 also, for a bit more clarity, with focus on Fig 1; the definitions 3.9; 3.10; 3.15; 3.17; 3.19; 3.20). Any information that hints at these requirements or lets say which the EU or FDA may leverage w.r.t to these points are the requirements.

What it means is, the manufacturer has to carefully analyze what you are displaying to the users or patient. For a SaMD it could be as simple as an advisory statement on the homepage (if a web application) or the default message printed on the generated reports, to as complicated as a specific way of configuration/ remedy, the information about which is provided on an User Manual. Thats it... not complicated at all but as tricky as it can get
 

Haresh

Involved In Discussions
Have a look at:
ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements. This standard is recognized by the EU and FDA.

EN 1041:2008
Information supplied by the manufacturer of medical devices
This standard is applicable to the EU market.

You can also look at labels for similar products online.

Goodluck,
Shimon
Dear Shimon,
I'm from pharma background, want to know is MDD certified medical device ( validity till 2024) have to furnish labelling requirement as per EU MDR ?
 

shimonv

Trusted Information Resource
To the best of my knowledge - no. There are some MDR elements like PRRC that manufactures are expected to follow during the transition period, but not labeling.
 
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