Marketing sticker for Medical Device outer box?

#1
Dear Team,
A short one linked to Medical Device labelling, if you allow me:

My products are medical device class III in Europe and class II in USA. I sell it in Europe and in USA already.

For Marketing purpose, I would like to add a small promotion sticker on the front face only of the package outer box. The sticker will be only placed on the package front face.

This sticker is a small icon and will not hide any other information of the packaging. All the mandatory regulatory icons and symbols will still be visible on the rear face of my package outer box (as it is today).

My questions to you:
1-Do MDR and FDA allow to have small promotional sticker on the package front face of medical devices?
2-If yes, are there specific requirements for the stickers?
3-If yes, do the entire package (with the sticker on) need to be retested in terms of biocompatibility or other tests?
4-Would you have the link to the MDR/FDA chapters/texts that address this topic?

Thank you very much for your support on this.
Thomas
 
Elsmar Forum Sponsor
#5
Yes, the content is different.
The brand that will appear on the sticker is a new brand that highlights the premium and high end category of the product. It will be different from the main brand.
I cannot disclose the brand name. One example is BMW cars with their "M" brand, which highlights the sportivity and exclusivity of the cars that hold the "M" icon/logo. Hope this is clearer. Thank you for your help.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
You need to be careful not to create an appearance that this is a new/different device. It's currently hard to be more specific.
 

dgrainger

Trusted Information Resource
#7
From the MDR:

Article 7
Claims
In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
(a) ascribing functions and properties to the device which the device does not have;
(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

If the devices are the same then you probably can't a label that ascribes "properties to the device which the device does not have" without re-assessing.
 
#9
From the MDR:

Article 7
Claims
In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
(a) ascribing functions and properties to the device which the device does not have;
(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

If the devices are the same then you probably can't a label that ascribes "properties to the device which the device does not have" without re-assessing.
Many thanks for your answer on this.
 
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