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Any violation with the use of RUO software with IVD instrument

S

sreenu927

Quite Involved in Discussions
#1
#1
Hi all..

We have an IVD device with CE marked and IVD software with it. Also an RUO instrument with CE marking and RUO software.

Afew EU hospitals want IVD instrument with RUO software to use for resarch use only applications.(they are insisting to have IVD instrument, but for RUO applications)

In all our IVD User documentation, we have included that any other validation of assays, otherthan the intended use, is the customer responsibility.

Now my question is, if we supply IVD instrument+IVD software and RUO software (as per customer request) and if he uses RUO software on the IVD instrument, will this be a violation related to off-label?

If the customer uses in the above manner, how to handle the customer complaints?

Look forward for ur response.

Thanks,
Sreenu
 
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Y

yana prus

#2
#2
Hi Shreenu,

if we supply IVD instrument+IVD software and RUO software (as per customer request) and if he uses RUO software on the IVD instrument, will this be a violation related to off-label?
Click to expand...
Have you reviewed the MEDDEV. 2.14/2 rev.1 IVD GUIDANCE : Research Use Only products?
http :// ec .europa eu/enterprise/sectors/medical-devices/files/meddev/2_14_2_research_only_product_en.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

It details list of possible situations where RUO products could be used and which therefore fall outside the scope of the IVD Directive.

Hope that helps,

Yana
 

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bio_subbu

bio_subbu

Super Moderator
#3
#3
Hi Sreenu

In vitro Diagnostic Medical Devices are regulated by Directive 98/79/EEC, according to the definition of an IVD set up in Directive 98/79/EEC and to MEDDEV 2.14/1 rev.1, an IVD "must be intended by the manufacturer to be used for a medical purpose. If no medical purpose is intended by the manufacturer then the product is not a medical device. Thus the intended purpose for a product will be key in determining whether or not the product is a (IVD) medical device."

According to MEDDEV 2.14/2 rev.1, a RUO product must have no intended medical purpose or objective. Therefore, an RUO product would not be CE marked under Directive 98/79/EEC.

Regards
S. Subramaniam
 
C

CarloCat

#4
#4
sreenu927 said:
Hi all..

We have an IVD device with CE marked and IVD software with it. Also an RUO instrument with CE marking and RUO software.

Afew EU hospitals want IVD instrument with RUO software to use for resarch use only applications.(they are insisting to have IVD instrument, but for RUO applications)

In all our IVD User documentation, we have included that any other validation of assays, otherthan the intended use, is the customer responsibility.

Now my question is, if we supply IVD instrument+IVD software and RUO software (as per customer request) and if he uses RUO software on the IVD instrument, will this be a violation related to off-label?

If the customer uses in the above manner, how to handle the customer complaints?

Look forward for ur response.

Thanks,
Sreenu
Click to expand...
Dear Sreenu,

you have to declare on the instrument's user manual (and in your technical file) the devices that can be used in combination with your products and any violation to the reported instructions are under customer's responsibility, as you properly did.
for eventual complaints you have to investigate them to be sure that the problem occurred is not due to your products but just to an incorrect use of them by the customer. only In this case you shouldn't need to notify it to the CA.

I suppose that your customers use the so called "home brew" products that are not (at the moment), covered by the 98/79/CE directive..
IVD directive is going to be changed in short time and lots of new classification will be done.
bye.
carlo
 
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