SaMD labeling requirements - MDR

TomQA

Involved In Discussions
Hi,

I have a question concerning the labeling requirements for an SaMD.
The european MDR's annex I section 23 sets out requirements for "information supplied with the device". However, in the context of a Software as Medical Device (SaMD) : what are the labeling requirements ? Do we need to find the information found on the label in the user interface ? Is the user interface considered as a "accompanying document" in the sens it can communicate to the users information related to safety (residual risks?).

Exemple : we need to add the new "MD" logo to our labeling, should this be present on the user interface too ?

I know that the UDI should be present but I am not sure for other labeling requirements.
Thanks for your help !
 

MaHoDie

Starting to get Involved
Hi TomQA,
First of all quick definition:
ISO 13485 and IMDRF use the term labeling (or labeling) as a synonym for accompanying information. There, labeling refers to all information supplied, including label and IFU (instructions for use).

According to this: labelling = accompanying documentation

accompanying documentation according to ISO 20417:
„information accompanying or marked on a medical device or accessory for the user or those accountable for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or accessory, particularly regarding safe use“

label according to ISO 20417:
„means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;“

Both definitions are similar to 21 CFR 201(m) and 21 CFR 201(k) respectively

Unfortunately, MDR and IVDR do not use the term label consistently, but use the term labeling synonymously in many places. This leads to confusion, as labeling has a different meaning than labels in other relevant regulations.

Back to your questions:


What are the labeling requirements ?
- All requirements applicable to your SaMD (consider risk class) according to Annex I Chapter III and standards like IEC 81001-5-1
- check if your SaMD requires an IFU (printed or eIFU)


Do we need to find the information found on the label in the user interface ?
- yes, where it reasonably applies. For example use an impressum (e.g. for web apps) to provide information regarding CE-mark, etc.


Is the user interface considered as a "accompanying document" in the sens it can communicate to the users information related to safety (residual risks?)
- If I understand this question right, in my opinion: no. To inform the user about residual risks via the UI this is not accompanying documentation, this would be a measure according to ISO 14971 (protective measure or information measure depending on the "place" in the UI)

Exemple : we need to add the new "MD" logo to our labeling, should this be present on the user interface too ?
- I guess "MD" meand medical device. If yes, than yes. You need to mark your SaMD as a MD properly (don't forgett the CE-Mark)



Check out EN 82304-1:2017 chapter 7.1 for some details: Here it is stated that:
"A HEALTHCARE SOFTWARE PRODUCT must be identified with the MANUFACTURER's name or trade name and a product name or type designation and a unique version identifier such as a revision number or release/publication date."
and
"The HEALTH SOFTWARE PRODUCT labeling must be accessible to the USER when using the HEALTH SOFTWARE."

There you find also information about accompanying document (chapter 7.2)

Does this help?
 

mihzago

Trusted Information Resource
A good place to include required information that typically goes on a 'label' such as the company name, product make, CE symbol, UDI, residual risks, etc. is an 'About/Help Menu' or a splash screen or another location within the software that the user can easily access.

Your user interface can be considered to be 'labeling' because it provides instructions or information for the proper use of the software device.
 

TomQA

Involved In Discussions
Hello !
thanks to the both fo you !
We also add the residual risks in a "disclaimer" document which the patient approves before using the SaMD (which should be considered as an accompanying document )
Thank you very much it's clear :)
 

TomQA

Involved In Discussions
@mihzago @MaHoDie
I have another question if you don't mind : is the "date of manufacture" symbol required for an SaMD ?
Or is the software version sufficient (for instance version 2.0.0) . Because there is no "date" in the software version?
Thanks !
 
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