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EU: Alcohol test kits for breast milk IVDD

Ben S UK

Starting to get Involved
#1
Hi,

Wondered if anyone had any thoughts or pointers on home use test kits to detect the presence of alcohol in breast milk? For the purpose of allowing the mother to chose whether or not to breast feed or formula feed.

I see quite a few of these breast milk test stripes are marketed, some devices are CE marked as IVDs, but several are not.

I've looked at the IVDD, as well as meddev 2.1/4 and the borderline manual and i'm not sure.

My first thought was to look at breathalysers to how these are regulated. Meddev 2.1/4 section 2.6 references kits used by law enforcement i.e. breathalysers and is clear these are not medical devices as the test is not for a medical purpose.

Then i tried to assess whether the intended use would be considered as a medical purpose. The borderline manual 1.19 has an example of a potential medical device (zeolite) and it states that, “the reduction of the absorption of ethylic alcohol, without any medical purpose, in order to reduce the blood content in alcohol cannot be considered as a medical purpose"

So would I be correct in thinking that a device which just informs the mother whether or not alcohol is present in her milk would not be deemed to be a medical purpose - on the assumption that even was for the purpose of preventing alcohol ingestion of a baby (via a Mother's decision whether or not to breast feed) this would not be a medical purpose and therefore outside the scope of the IVDD?

Ben
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Prevention also falls under the Medical Device definition.
The device may be intended for preventing <insert something> in the infant.
 

twanmul

Involved In Discussions
#3
This is just my personal opinion, though I think that under the existing directives, your device possibly doesn't have a medical purpose, though the example in the borderline example doesn't help your case.

Under the new Regulations however, this is likely to be classed as an IVD medical device. The reason for this would be that it meets the definition of a medical device under the Regulation in the following way:
"‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:

devices for the control or support of conception;

products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point."


It will also meet the definition of an IVD medical device in the following way:
"‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;"


In either case, you should probably undertake your own objective assessment and discuss with your Notified Body as a first port of call.
 
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