Medical Device Labeling Content Question

A

Anon7111

#1
Does anyone no what ISO standard or EU directive requires the material (substrate, coatings, etc.) to be included on the product label? If there is no requirement out there, do you think that the best way to respond to this type of question would be to say that we think the information included on the current label is sufficient as their is no external standard or MDD directive that requires this?
 
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M

MIREGMGR

#2
There must be a context for this question...something about the device type, intended use, design, etc. that causes the question-asker to think they need to know.

In the general case your labeling only has to provide the information specified by the MDD and any relevant standards. On the other hand, perhaps there is something about that contextual information that makes additional information important to the safe and effective use of your device.

Do you want to explain the situation a little more?
 

DannyK

Trusted Information Resource
#3
Does anyone no what ISO standard or EU directive requires the material (substrate, coatings, etc.) to be included on the product label? If there is no requirement out there, do you think that the best way to respond to this type of question would be to say that we think the information included on the current label is sufficient as their is no external standard or MDD directive that requires this?
Depends on the intended use of the medical device and who the intended users are.
The MDD is a general document and will not specify ant specific labeling requirements except for what is already specified Annex I , ER 13.3. Your risk analysis process should review what is required on your label and what are the risks for not including the information.
You should be able to discuss this specific topic with the scheme manager of your notified body.
 
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