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To Identify the Applicable MDD Directive - Prepared blood smear

T

Thukira

#1
HI.. there is product in which prepared blood smear is used as input for the laboratory product..,

Will the product comes under IVD ?

Please help...
 
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pkost

Trusted Information Resource
#2
the definition of an IVD is:
‘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;
I've highlighted relevant sections...It most likely is an IVD if the blood is used for a medical purpose instead of just research and is specfiically intended as such, but if it is just a piece of lab equipment then it isn't an IVD
 
T

Thukira

#3
It is intended to use in laboratory..which is used for pathology study results based on blood smear slide..
IEC 61010-1 - safety and IEC 61326-1for Emc/I
Apart from these, any other STDs will apply?

IEC 62304 and IEC 60601-1-6, 62366 will not apply as it is not a medical device.

PL clarify
 
T

Thukira

#5
Need clarification for the below

From the definition it follows that in order to be qualified as an IVD the product must first fulfil the definition of a medical device and therefore must be intended by its manufacturer to be used for a medical purpose.

But this is classified as "Laboratory Device"

Still IVD apply ?

And also could see 62366 and 62304 under IVD directive - hope that also will apply for "medical device" not the "laboratory device"

Pl clarify
 

pkost

Trusted Information Resource
#6
If I sell a test tube to you, and don't say much about what it is used for, it's probably not an IVD even if you chose to use it to hold blood while testing for a particular condition

If I sell a test tube to you and say that it is for storing blood during a test for a medical condition, it is an IVD
 
T

Thukira

#7
Thanks everyone for your inputs.

Adding to the above; the products works with 12V supply; our NB says that LVD also will apply

The LVD 2014/35/EU, ANNEX II: Equipment and Phenomena Outside the Scope of this Directive states, Electrical equipment for radiology and medical purposes, but there is no definition of medical purposes in the LVD directive.

I would like to know that for an IVD, MDD, do we need to comply to LVD Directive? as it explicitly states exclusion for medical purposes.

In my understanding where the MDD, or IVD is applied the LVD is N/A. The electric safety of the device will be addressed via the IVD’s/MDD's essential requirements, which I think are more detailed and more onerous especially if we take into account that the highway to IVD/MDD electrical compliance is via EN 60601, EN 61010.


Pl clarify
 

pkost

Trusted Information Resource
#8
You say that it uses a 12V supply, is this transformed to a higher voltage at any point? article 1 (scope) is quite clear what LVD applies to:
This Directive shall apply to electrical equipment designed for
use with a voltage rating of between 50 and 1 000 V for alternating
current and between 75 and 1 500 V for direct current
12V is clearly outside of these ranges and therefore LVD does not apply
 
T

Thukira

#9
Is there any directive for equipment which works on 5V and 12V supply?
As our NB says LVD will apply?
 

pkost

Trusted Information Resource
#10
I'm not aware of any other directive that applies to 5-12V

You will have to ask why they think LVD applies, specifically point out article 1 states that LVD only applies in higher voltage ranges and ask them to justify their reasoning
 
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