Are pipette heads "medical devices"?

andrei iuganu

Involved In Discussions
Hello group. I'm a beginner in this field anyway, so I'm asking for your help. I have the following situation: a manufacturer injects pipette heads, the storage rack, box and thebox lid. They sell as a final product the box with rack, pipette heads and lid. My questions are:
Hello group. I'm a beginner in this field anyway, so I'm asking for your help. I have the following situation: a manufacturer injects pipette heads, the storage rack box and the head. They sell as a final product the box with rack, pipette heads and lid. My question is: are pipette heads "medical devices"? for the final product what type of label do I need? UDI ID? I am very confused by the terminology.

Thx in advance.
 

Ninja

Looking for Reality
Trusted Information Resource
Howdy,

I'm not in medical, so I'll let someone who is answer your direct question.
It occurs to me, however, that not being in medical, I use pipettes and buy the product you describe for wet chemistry analysis (Na+ content, etc.).

I don't think you can draw the line all the way up at "A pipette head is/is not"...the line would have to be a bit closer to intended use or customer segment.

We'll both learn from someone who knows soon.
 

chris1price

Trusted Information Resource
I think you can safely say they are not Medical Devices. However they may fall under the In-vitro Diagnostic Regulation (IVDR). It depends what they are intended to do. Check the definitions under Article 1 of the IVDR. If the pipette heads are general purpose products, ie are not directly linked to a specific IVD then they are not covered by the regulation. If the pipettes are intended for a specific diagnostic kit, then they are covered.

The easiest way is to look at a competitors product. If the label contains a CE Mark, then they are covered by the regulation or directive. If that's the case, then there are lots more questions to be answered.
 

William55401

Quite Involved in Discussions
Careful. My goto is the FDA Registration and Listing database. Search on "pipette" as device name and there are hits. Here's an URL of interest.

Establishment Registration & Device Listing

A pipette, when used in a med device application, is a med device.

A quick look at one firm's product show these classified by the US FDA as Class I. As you click into the Registration (info about the firm that holds the listing) and then click into the listing (info about the Device), you will have more questions. Hope this helps. Have fun. Enjoy the ride!
 

andrei iuganu

Involved In Discussions
Careful. My goto is the FDA Registration and Listing database. Search on "pipette" as device name and there are hits. Here's an URL of interest.


A pipette, when used in a med device application, is a med device.

A quick look at one firm's product show these classified by the US FDA as Class I. As you click into the Registration (info about the firm that holds the listing) and then click into the listing (info about the Device), you will have more questions. Hope this helps. Have fun. Enjoy the ride!

Maybe it was important to specify that the manufacturer is in Europe? I found in a bsi brochure if I interpret correctly the head pipettes would be class A, rule 5 and do not require any labeling UDI until 2027. Do I interpret correctly?
 

William55401

Quite Involved in Discussions
Yes, where you are marketing / intending to market defines the rules you must abide by. To be honest, I am not deep into product classification on the EU side. I am more of an FDA guy. As you work through this, be mindful that rules change. For IVD, the current regulation is IVDD. Coming soon, is the IVDR. IVDR makes significant classification changes. You may have a solution now for MDD and then adjust as IVDR goes into effect for your particular product(s). HTH. Have fun. Enjoy the ride!
 

Tidge

Trusted Information Resource
I have not done a registry search, but if they are marketed with a medical application, they are medical devices. I would expect them to be class 1.
 

andrei iuganu

Involved In Discussions
Thanks to everyone for the answers. I'm totally confused. Can someone guide me exactly to the text of the law for Europe from which to document what the pipette heads - class, if it is or is not a medical device, and whether or not I need the UDI label and CE marking. Thank you very much.
 

chris1price

Trusted Information Resource
I recommend you find a copy of the MDR regulation (2017/748) and the IVD Regulation (2017/746), I have quoted the definitions below. Its best for you to decide whether your products are a medical device or not; or an In-vitro diagnostic or not. Once you decide that, you can work out the class of the product and whether you need a UDI.



From MDR

(1) '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 subparagraph of this point.

(2) 'accessory for a medical device' means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);


From IVDR
(2) '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
 

LUFAN

Quite Involved in Discussions
I think you can safely say they are not Medical Devices.

IVD devices ARE medical devices. They are governed by separate directives/regulations in Europe, but there is no distinction between the fact that they are both medical devices. FDA defines them the same way.

From IVDR
(2) '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
 
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