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Can an IVD kit be used on RUO Instrument as per EU (and US) regulations?

S

sreenu927

Quite Involved in Discussions
#1
#1
Hi All,

Can a IVD kit be used on RUO Instrument as per EU (and US) regulations?

The kit(IVD) is sold alone for the detection of some influenza virus. The customer can buy this and this is used in instrument (RUO) to get the analysis.

Both the instrument and kit are sold separately. Instrument can be used with any type of such kits and kits can also be used with any other similar instrument.

Can the manufacturer of IVD kit, promote the usage of the kit along with the RUO instrument??

Also,how can we control the user who is using the RUO instrument as we don't have that visibility on which instrument the user is using the IVD kit, if manufacturer is not promoting with RUO instrument?

The IVD kit can also be used with IVD instruments.

Thanks in advance!

Regards,
Sreenu
 
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V

Vincnet

#2
#2
sreenu927 said:
Hi All,

Can a IVD kit be used on RUO Instrument as per EU (and US) regulations?

The kit(IVD) is sold alone for the detection of some influenza virus. The customer can buy this and this is used in instrument (RUO) to get the analysis.

Both the instrument and kit are sold separately. Instrument can be used with any type of such kits and kits can also be used with any other similar instrument.

Can the manufacturer of IVD kit, promote the usage of the kit along with the RUO instrument??

Also,how can we control the user who is using the RUO instrument as we don't have that visibility on which instrument the user is using the IVD kit, if manufacturer is not promoting with RUO instrument?

The IVD kit can also be used with IVD instruments.

Thanks in advance!

Regards,
Sreenu
Click to expand...
Hi Sreenu,

My vision: I understand that the kit is sold as an IVD! So it always end up to the user's responsibility in what they are doing. If they provide a diagnostic they need to control their instruments, and they need to have some proofs of validation of the test. The simple way is to use IVD tagged tests and systems but they could also go for the more complex route of doing full validation in house. It's their choice.
Your responsibility as manufacturer distributor is to ensure that used correctly the test is reliable within your defined limits.
So as you can't control what is done with the kit I wouldn't promote the kit usage with an RUO system.

V
 
bio_subbu

bio_subbu

Super Moderator
#4
#4
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.

Directive 98/79/EEC does not regulate the use of the IVD medical devices, therefore a user which would use an IVD for RUO purpose would do it under its own responsibility.
 
A

AG Kumar

#5
#5
bio_subbu said:
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.

Directive 98/79/EEC does not regulate the use of the IVD medical devices, therefore a user which would use an IVD for RUO purpose would do it under its own responsibility.
Click to expand...
A alteration of the said question - Can we use a RUO kit in an IVD registered product? Will the RUO regulations (both in US and EU) permit this?

Please clarify.

G Kumar
 
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