Use of Phthalates (PVC) - MDD 2007/47/EC - Has anyone started Labelling Devices

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Peter Madison

#52
Our single use medical device is maufactured with all biocompatible medical grade materials not containing phthalates. However, the PVC caps which we have planned to use to protect the working tips do contain DINP type phthalate. My question is that since these protective caps are thrown away after the package is opened and do not come into contact with human body, do they fall under the Medical Device Directive requirement to not to have the phathalates? The material of these caps is also medical grade. Do the labels require any mention of phthalates?

I will appreciate if gurus on this great platform can help us.:thanx:

Hi Abbas,

The section 7.5 of Annex I of the Medical Device Directive 93/42/EEC states that (in para 2):
' If parts of a device (or a device itself) intended to administer and/or
remove medicines, body liquids or other substances to or from the
body, or devices intended for transport and storage of such body
fluids or substances, contain phthalates which.....'


Based on your description, the PVC does not administer and/or remove medicines, body liquids or other substances to or from the body.

So, there is no need to test the PVC cap for phthalates and hence no labeling requirement.

Hope this answers your question.
 

Michael Malis

Quite Involved in Discussions
#53
Hi Abbas,

The section 7.5 of Annex I of the Medical Device Directive 93/42/EEC states that (in para 2):
' If parts of a device (or a device itself) intended to administer and/or
remove medicines, body liquids or other substances to or from the
body, or devices intended for transport and storage of such body
fluids or substances, contain phthalates which.....'


Based on your description, the PVC does not administer and/or remove medicines, body liquids or other substances to or from the body.

So, there is no need to test the PVC cap for phthalates and hence no labeling requirement.

Hope this answers your question.
Peter,

Let me try to clarify.
From Abbas information, you can't provide a "no labeling required" answer.
PVC part is part of the device. We don't know if this device is "intended to administer and/or remove medicines, body liquids or other substances to or from the body".
If the answer is yes - than you need to label, even if there is no risk present! Even if this does not make common sense, MDD does not provide us with any leeway for not labeling!
However, based on the definition in MDD, you must answer "yes" on all points in the order to label:
1. If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the
body, or devices intended for transport and storage of such body
fluids or substances, contain phthalates and
2. Phthalates are Category 1 or 2 from Directive and
3. Phthalates in this material are an integral part of the material formulation
If you answer "no" on any of the Q above, - you don't need labeling!

Hope it helps,
Mike
 
P

Peter Madison

#54
Peter,

Let me try to clarify.
From Abbas information, you can't provide a "no labeling required" answer.
PVC part is part of the device. We don't know if this device is "intended to administer and/or remove medicines, body liquids or other substances to or from the body".
If the answer is yes - than you need to label, even if there is no risk present! Even if this does not make common sense, MDD does not provide us with any leeway for not labeling!
However, based on the definition in MDD, you must answer "yes" on all points in the order to label:
1. If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the
body, or devices intended for transport and storage of such body
fluids or substances, contain phthalates and
2. Phthalates are Category 1 or 2 from Directive and
3. Phthalates in this material are an integral part of the material formulation
If you answer "no" on any of the Q above, - you don't need labeling!

Hope it helps,
Mike
Hi Mike,
Thank you for the clarification.

I do agree that if the answer to all 3 points you have stated is "Yes" then labeling for phthalates is a must.
But, Abbas has clearly stated that their device is manufactured by using only biocompatible medical grade material and contains no phthalates. His question was only about the PVC cap that goes on the device. The PVC cap ("part of the device")contains phthalate and the cap is discarded prior to using the device. So regardless of whether or not the device meets point # 1 requirement, there should be any need to label the device for phthalates. Also the PVC cap ("part of the device") doesn't do anything as stated in #1.

I would appreciate your feedback on this. Thank you.

-Peter.
 

Michael Malis

Quite Involved in Discussions
#55
Peter,

I agree with your risk rationale.
Unfortunately, this is not what MDD dictates.
I already used the same rational with my registrar (the part is not present during the infusion process and therefore, no risk) and also raised this to a Competent Authority, - only to be told that we need to label for phthalates because my part is the "device itself". However, my registrar allowed this language in the IU: "Because the part (containing phthalates) is not present during the infusion process, - there is no risk present..."!!!

So, if material was manufactured with phthalates as an integral part of the formulation - you need to label the device for phthalates and only after that you can use the risk rational to define your information in IFU.

I hope this is clear and helpful.

Regards,
Mike
 
Last edited:
P

Peter Madison

#56
Peter,

I agree with your risk rationale.
Unfortunately, this is not what MDD dictates.
I already used the same rational with my registrar (the part is not present during the infusion process and therefore, no risk) and also raised this to a Competent Authority, - only to be told that we need to label for phthalates because my part is the "device itself". However, my registrar allowed this language in the IU: "Because the part (containing phthalates) is not present during the infusion process, - there is no risk present..."!!!

So, if material was manufactured with phthalates as an integral part of the formulation - you need to label the device for phthalates and only after that you can use the risk rational to define your information in IFU.

I hope this is clear and helpful.

Regards,
Mike
Thank you once again, Mike. This is indeed very helpful to know.

Well, with my personal experience and with your's with the registrar and the Competent Authority, I would say that different registrar's have different interpretation about the requirement.

-Peter.
 

Michael Malis

Quite Involved in Discussions
#57
Thank you once again, Mike. This is indeed very helpful to know.

Well, with my personal experience and with your's with the registrar and the Competent Authority, I would say that different registrar's have different interpretation about the requirement.

-Peter.
Peter,

You are correct!

Until MDD is modified my other reccommendation on this subject:
1. Make sure that you do the right survey when collecting material information to cover all phthalates in Class 1 and Class 2 of Directive.
2. Ask your material supplier to certify that phthalates present are "integral part of the material formulation" or not. "No" answer will not requre labeling.

Mike
 
P

Parsha

#58
Hi everyone, I have looked almost all the articles which related to "Phthalates"
Regarding the labelling, still very confused. Hope anyone could share some experience.
During the discussion with my 3rd party auditor, we know that we have to do the labelling if we have any PHT in the product.
But....
1. do we need to specified on the label that which PHT we used? there is one time, our 3rd party auditor told us, only specified if we use DEHP; however, after few months, they said is no need to specify DEHP...(very confused)
2. does any document said we only need to do the labelling if the PHT is above ?% ?

Appreciate if anyone could share your experience,

Thank you~:eek:
 
Last edited by a moderator:

Stijloor

Staff member
Super Moderator
#59
Hi everyone, I have looked almost all the articles which related to "Phthalates"
Regarding the labelling, still very confused. Hope anyone could share some experience.
During the discussion with my 3rd body, we know that we have to do the labelling if we have any PHT in the product.
But....
1. do we need to specified on the label that which PHT we used? there is one time, our 3rd body told us, only specified if we use DEHP; however, after few months, they said is no need to specify DEHP...(very confused)
2. does any document said we only need to do the labelling if the PHT is above ?% ?

Appreciate if anyone could share your experience,

Thank you~:eek:
Welcome to The Cove Forums! :bigwave: :bigwave:

Please clarify "3rd body". Do you mean a 3rd Party Auditor?

Stijloor, Forum Moderator.
 
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