MDR labeling requirements: primary vs secondary packaging

DannyVerbiest

Starting to get Involved
Hi,
We are designing the artwork for our over-the-counter class IIb medical device.
The MDR and guidelines are quite clear on what the minimum requirements are in terms of text, data, symbols and warnings.
However, it is still unclear to me what needs to be printed on each level of packaging.

Our product is a pressurized cannister (eg hairspray or deo) that is packed in a carton box incl IFU.
Does the legal manufacturer and distributer need to be mentioned on the cannister? or is the box sufficient?
Same goes for intended use, does this need to be on the primary packaging? We prefer not to do this allowing us to mass produce the cannister in 1 version and adapt the carton box to the different distributors and markets (language adjusted).

Curious to hear your opinion on this.
Thanks in advance,
Danny
 

Vetty007

Involved In Discussions
Your approach doesn't make sense as the product itself must contain the relevant information esp. as it might be separated from the carton box when in Use and then the minimum information needs to be given, which includes the intended use. Additionally I expect, that the product might fall under chemical law for labelling of the product as well as the packaging. In most cases the product is delivered to several countries, the labelling is done with a booklet/multilayer label containing the relevant languages. Otherwise there is often a multilanguage (colored) front label and an individual (black-white) label on the back (printed inline during manufacturing). The box labelling is done acc. to the individual needs for shipping, which also needs to fullfill the transport labelling requirements.
 

DannyVerbiest

Starting to get Involved
Hi Vetty007, thanks for your input! Much appreciate it! Especially the booklet label is something I hadnt thought of myself.
You are basically stating that all label information should be on each level of product packaging. I understand your reasoning, but being part of a small scale start up, I would still want to challenge this. Production of our product in cannisters is cheaper when the order volume is higher. However it is impossible to create 1 cannister art-work, that is containing all information/warnings/claims in all languages. Furthermore, in some countries we will use a distributor to help us sell the product. In that specific case, the distributor needs to be mentioned.
It would help us if we could make a very basic cannister artwork with the mutual information on booklet label and then create a country specific carton box to put the cannister in (containing distributor info etc..)
 

Vetty007

Involved In Discussions
Yes, I know that situation very well and I also meant, that the carton label should be country specific. Since there is only a small number of quantities just use a multilingual, professionally printed front label and use a self printed back label (good quality of course, could be a cheap black-white lable) in the respective language. In order to remain cost-efficient and to make the whole thing feasible, you can specify country groups for the multilayer labels, giving the relevant information and taking into account the language requirements of the individual countries (don't mix up language and country, there are countries requiring more than one language to give). Possibly you may have 2-3 multilayer label versions for different sales country groups. This is often combined, i.e. individual back labels for very small quantities and multilayer back labels for larger quantities - the front remains the same..... This is feasible, but requires a good planning and also don't forget the IFU, so not everything has to be on the product itself. Although canisters allow for larger labels and thus more information can be given on it, avoiding the need for delivering IFUs with them. I am pretty sure, the label issue can be solved :)
 
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