Labelling of Medical Devices with DEHP (Di(2-ethylhexyl) phthalate)?

DianaBC

Starting to get Involved
#1
Hello each one of you!

I am new in this "dance" and I do need some indulgence from you.
What about the labelling of medical devices with DEHP?

Any experience / practice in this area could help me a lot.
:eek:
 
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Marcelo

Inactive Registered Visitor
#2
Re: Labelling of medical devices with DEHP?

Hello Diana

Generally, labeling is related to a particular regulatory system, due to the nature of the regulations. Do you want to know about the labeling of products with DEHP in Europe, or your question is more general?

I do not have any experience with this subject, but surely other Covers will help you.
 

Michael Malis

Quite Involved in Discussions
#5
I think perhaps the most useful recent thread is one that focused on the term "phthalates" rather than "DEHP", and thus isn't listed in the above search:

http://elsmar.com/Forums/showthread.php?t=31626

The Eucomed position paper mentioned in that thread, has since been updated to:

http://www.emki-korhaztechnika.hu/site/conf/upload/EUCOMED_GUIDE_2_Draft.doc
Also check with your Notified Body, because not all of them follow Eucomed guidelines. I just have this issue with NSAI...
 
M

MIREGMGR

#6
A further thought: the earlier thread focused on the interpretation from the preliminary Eucomed guidance that the amended MDD language calling for labeling of DEHP content in devices to be used for removing biological fluids was to be interpreted as implicitly containing the qualifier that the biological fluids were being removed with the intent of later re-introducing them.

The new, presumably final Eudomed guidance does not contain this interpretation, at least as I read it. Now its content is much more narrowly aligned with the unclear meaning of the MDD wording. Thus it is much less helpful to those of us who make flexibilized-PVC medical devices intended for the removal of biological fluids, where the proximity but theoretical non-contact and non-migratory context of the PVC elements of the device to the patient will lead to applicability disputes.
 

DianaBC

Starting to get Involved
#7
Re: Labelling of medical devices with DEHP?

Hello Diana

Generally, labeling is related to a particular regulatory system, due to the nature of the regulations. Do you want to know about the labeling of products with DEHP in Europe, or your question is more general?

I do not have any experience with this subject, but surely other Covers will help you.
My question was indeed more general....because the same products are sold in Canada, Australia, Europe...therefore I was trying to get a uniform method of indicating the presence of phtalates....not to mention that more customers are questioning about the percentage of phtalates contained in a product...

Is there a instrument that calculates the % of phtalates from a product?

It may sound stupid....but I take my changes....
 
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