Certificate of Analysis: Cuvettes & Magnetic Stirrers

B

belemsanchez

#1
My company manufactures IVD medical devices and accesories at UE. One customer has required to us about certificate of analysis of our cuvettes and Magnetic stirrers. Both of them are used in Coagulation Analyzers. So, please, these accesories has to be designed according any regulation? How can we write these certificates of analysis?
Thanks a lot because I'm very lost in this item.
 
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Stijloor

Staff member
Super Moderator
#2
My company manufactures IVD medical devices and accessories at UE. One customer has required to us about certificate of analysis of our cuvettes and Magnetic stirrers. Both of them are used in Coagulation Analyzers. So, please, these accesories has to be designed according any regulation? How can we write these certificates of analysis?
Thanks a lot because I'm very lost in this item.
Suggestions anyone?

Thank you!!

Stijloor.
 

pkost

Trusted Information Resource
#3
take a look at the definitions below, and specifically the bits I have highlighted in bold:

(a) ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

(b) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, 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:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;


(c) ‘accessory’ means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose. For the purposes of this definition, invasive sampling
devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices;
If your device falls into these definitions they are covered by the IVD directive (98/79/ec) for sale in the EU and should conform to the regulations.

with regards to a certificate of analysis, there are plenty of examples of certificates of analysis on google which you can see. I'm not entirely sure what analysis someone would want for a curvette or magnetic stirrer. I would ask them to clarify exactly what they want in the certificate.
 
B

belemsanchez

#4
Thanks a lot, yes, our Cuvettes & Magnetic Stirrers are not considered IVD by us, the manufacturer. I'm going to ask our customer because I'm still confusing.
I've looked for a sample of this, but I haven't found it.
 
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