Address on Label Requirements (MDD Annex I 13.3(a))

M

mr.mike

#1
Hello once again,

My question this time has to do with labelling requirements as stated in MDD Annex I, specifically paragraph 13.3 (a).

The requirement calls for an address to be present on the label.

First of all, is there a definition of "The Label"? I was looking for one in the definitions section (Article I), but couldn't find one.

Here's our conundrum:
- Presently we have only our name, website and phone number on the labels affixed to the device itself.
- The packaging box, and accompanying User Instructions, however, include our complete mailing address as well, and an email address.

What I'm hoping is that the latter is sufficient to fulfil this requirement. This is because our device labels are pre-printed, and expensive to redo. Packaging & User-Instruction labels/docs, on the other-hand, are printed as needed, and easy to modify if needed.

Judging from other threads, this is likely an "Ask your Registrar because they all interpret differently" case. Nonetheless, if anyone had any experience or advice to share, it'd be much appreciated.

thanks in advance,
MM.
 
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M

MIREGMGR

#2
Presently we have only our name, website and phone number on the labels affixed to the device itself.
And also the product's CE Mark...?

- The packaging box, and accompanying User Instructions, however, include our complete mailing address as well, and an email address.
And presumably the name and contact info for your EC Rep, and any other regulatorily required information?

The argument I've heard in the past in support of 13.3a is that the outer box is more likely to be discarded at a location and time separate from the eventual end-use, when an adverse event might occur and a decision would be made that the responsible manufacturer must be contacted.

It seems to be a weakly justified requirement in the case of a device that's accompanied by IFU and that in any case is directly marked with a phone number and email address, but that's how it's been explained to us.
 

somashekar

Staff member
Super Moderator
#3
Hello once again,

My question this time has to do with labelling requirements as stated in MDD Annex I, specifically paragraph 13.3 (a).

The requirement calls for an address to be present on the label.

First of all, is there a definition of "The Label"? I was looking for one in the definitions section (Article I), but couldn't find one.

Here's our conundrum:
- Presently we have only our name, website and phone number on the labels affixed to the device itself.
- The packaging box, and accompanying User Instructions, however, include our complete mailing address as well, and an email address.

What I'm hoping is that the latter is sufficient to fulfil this requirement. This is because our device labels are pre-printed, and expensive to redo. Packaging & User-Instruction labels/docs, on the other-hand, are printed as needed, and easy to modify if needed.

Judging from other threads, this is likely an "Ask your Registrar because they all interpret differently" case. Nonetheless, if anyone had any experience or advice to share, it'd be much appreciated.

thanks in advance,
MM.
Hi Mike ~~
I will never link cost to regulatory requirements.
When the device is so small that the label on it cannot contain the address as required per the MDD legible and readable, then it has to have the proper symbol leading the user to the IFU where it is contained, and take the next optimum packaging label to put in the address.
The 13.1 and 13.2 of the MDD Annex I gives good practical guidelines.
 
Last edited:
M

mr.mike

#4
Hi Somachekar & MIREGMGR,

MIREGMGR: Yes, the CE marking is on the device labels.

Somachekar: We have the IEC 60878 symbol for "Follow Operating Instructions", plus the actual text "Read Instructions Before Operating" on a label on the device.
Do you think this is sufficient to allow exclusion of our address on the device itself?
(given, of course, that detailed contact info is included in the IFU).

I'm still confused though.
What is the definition of "The Label" (Annex I 13.3)?

We have several labels on our device, as well as packaging labels.
Also, there is a smaller, removable part, that bears its own label mirrorring the information on the main-device (CE mark, Company name & address, serial number, country of manufacture...).
But due to restricted space, this label does NOT have the aforementioned "Follow Operating Instructions" symbol.

Also, there is a computer that is part of the system. This has only our internal part number, as well as the computer's manufacturer's detailed label.

I guess my confusion boils down to the following:

1) Are the requirements outlined in Annex I 13.3 so strict that all the information MUST be on the device itself, or (as with our address) is it sufficient just to refer the user to the IFU (with a symbol & text on the device).

2) Are the required label information outlined in Annex I 13.3 required on every label of every part of the device (e.g. in our case: main device, removable part & accompanying computer)? ...or is "device" treated as the entire, connected, functioning system, in which case a the info required by 13.3 can be on a single label attached to the main device?

Hope I'm not being to confusing with my confusions... ;)
MM.
 
#5
We were given a 'non-conformity' by our notified body because we did not have the full address on our label. We had web address, town and country and also 'Read Operators Manual' symbol but had to add the full postal address.

My understanding is that 'label' means all of the markings on a device.

I believe that the only justification not to have all required elements is that of small device size making it impractical. This may apply to the detachable parts you mention.

We include our address on our serial number label, so it's not too difficult to change if needed.
 
T

The Specialist

#6
Can information that cannot be written in full be applied using data matrices, such-as 2D matrix/barcode?

Or does the information have to be 'commonly' legible?

Just a thought. ( I am not in the know on this topic)
 
K

Ka Pilo

#7
Slightly :topic:
I’m curious how the requirements e.g. user instructions, complete mailing address, email etc will fit to small products/packages. Otherwise, it will be affixed separately.
 
#8
To quote direct from MDD Annex 1 13.1

"As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in
the leaflet supplied with one or more devices."

So any deviation from comprehensive labeling becomes something to consider in your risk management process. The same applies to 'non-human readable' information (barcodes or matrices).

So if your device is for use in a home care setting then the likelihood that they will be able to read the barcode is nil. But a container for use in a dispensary where barcodes are already in use - then it may be OK.
 
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