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

S

SteveK

#11
Re: Use of phthalates - MDD 2007/47/EC

Red,

I'd just found this link myself - but thanks for posting (I was about to!). FYI the symbols are identical to those in the most up to date draft standard - obviously taken directly from this. It looks like the standard reference will be EN 15986.

Steve
 
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C

cwokeeffe

#12
Re: Use of phthalates - MDD 2007/47/EC

Question on this post. Does the phthalate need to be "an integral part of the medical device" or does it need to contain a phthalate (per Annex 1 7.5 of MDD). Basically, I'm asking if we should label if it is a minor part of the base resin.

Thanks!
 
S

SteveK

#13
Re: Use of phthalates - MDD 2007/47/EC

Quote from Eucomed:

5.0 Labelling

5.1 Decision to apply the labelling:

The presence of Phthalates will not automatically require specific labelling.

The labelling is required when all of these elements apply:

 The device contains phthalates AND
 The phthalates are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC AND
 The phthalates are present above a threshold of 0.1% w/w AND
 The device is intended to administer and/or remove medicines, body fluids or other substances to or from the body or devices intended for transport and storage of such body fluids or substances, however, only for the purpose of (re)entering the body AND
 The phthalates might possibly leach out of the medical device and possibly expose to the patient via administration of medicines, of body liquids or other substances AND
 The quantity of Phthalates which can leach to the patient is above the recognized acceptable daily intake for reproductive toxicity or the device is intended to be used explicitly for treatment of children or treatment of pregnant or nursing women. Today ADI limits are under development by ISO TC194 WG11 using as the reference material a well recognized standard “EN ISO 10993-17:2002, Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances”
 
M

MIREGMGR

#14
Re: Use of phthalates - MDD 2007/47/EC

Quote from Eucomed:

5.0 Labelling

5.1 Decision to apply the labelling:

The presence of Phthalates will not automatically require specific labelling.

The labelling is required when all of these elements apply:

 The device contains phthalates AND
 The phthalates are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC AND
 The phthalates are present above a threshold of 0.1% w/w AND
 The device is intended to administer and/or remove medicines, body fluids or other substances to or from the body or devices intended for transport and storage of such body fluids or substances, however, only for the purpose of (re)entering the body AND
 The phthalates might possibly leach out of the medical device and possibly expose to the patient via administration of medicines, of body liquids or other substances AND
 The quantity of Phthalates which can leach to the patient is above the recognized acceptable daily intake for reproductive toxicity or the device is intended to be used explicitly for treatment of children or treatment of pregnant or nursing women. Today ADI limits are under development by ISO TC194 WG11 using as the reference material a well recognized standard “EN ISO 10993-17:2002, Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances”
This statement says "the labeling is required" (my bold), implying currency as a standard or directive.

Is information available regarding the standard/directive/other source from which Eucomed derived the above guideline, particularly the fourth point? Some previous information sources have indicated that the rules would apply to all medical device uses of phthalate-plasticized PVC with direct or indirect patient contact. Limiting the scope to just fluid circuit components is a dramatic diminuition of that extent of applicability.
 

Peter Selvey

Staff member
Super Moderator
#17
I have not seen yet mention here of the draft standard prEN 15986, which gives the format of the labelling in question (many thanks to Intertek for thier rather nice guide on the revised MDD).

Just for reference, my understanding of the directive is that until this standard is published in the official journal there is no legal need for action, even after March 21, 2010 (there is a long explanation here but that's a bigger subject).

Of course in practice I would recommend using the draft standard to trigger the design change, but hold off production until the EN is published. This ensures that on the day the official journal is updated you will be meeting the harmonised standard, and should keep your notified body happy as well.
 
R

red_wood

#19
Thanks everyone for the very informative discussion on phthalates labeling...

Our notified body have commented that all devices requiring phthalates labeling be labeled by 21 March 2010 for goods going into EU. We were advised to use the draft symbol while waiting for the official release of the standard. As such, we had triggered the change at production level. There are also products in the warehouses that we had to deal with...

If we can wait till the standard is official released, it would definitely buy us more time. Does anyone know of the official stand that EU is taking for this phthalate labeling?

Thanks in advance! :)
 

Peter Selvey

Staff member
Super Moderator
#20
Sorry for the slow reply, I've been offline.

A notified body should not require a draft or non-harmonized standard to be used, in practice their best shot is to say that the non-harmonised documents should be viewed as an input to your risk management process, which allow for action in the case that significant risks exist which is not worth waiting for the harmonisation process to be completed. This argument is valid because EN ISO 14971 is a harmonized standard, and it in turn it is reasonable that draft/non-harmonized standard provide material for identifying hazards, and also may establish state of the art.

As for phthalates labeling, I'm not an expert, but I was assuming that we are not talking about any significant risks. Thus, waiting for at least the publication of the standard seems reasonable. There may be special cases where immediate action could be warranted, but in this case waiting for March 21, 2010 is equally not justified.

You may ask what to do since the essential requirement is so specific (labelling is required). Well, it's a long story but basically there is no legal requirement to answer essential requirements directly, as long as all harmonized standards are applied. If you look closely the MDD is a bit of a mess for this point (there is some history here going back to 1984, far too long to explain here). But the upshot is, in my professional opinion, where there is no harmonized standard for an essential requirement, only EN ISO 14971 must be applied. So, see the two paragraphs above.
 
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