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IVD (In Vitro Diagnostic) MDD (Medical Device Directive) Borderline Issues

G

GPjeri

#1
I'm looking for anything more current than 2004 that speaks to IVD MDD borderline issues. We have a sterile swab used in an IVD kit that one NB says is a med device. We've tried to challenge this but so far hit a brick wall.

Thanks in advance for your input !
 
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Stijloor

Staff member
Super Moderator
#2
I'm looking for anything more current than 2004 that speaks to IVD MDD borderline issues. We have a sterile swab used in an IVD kit that one NB says is a med device. We've tried to challenge this but so far hit a brick wall.

Thanks in advance for your input !
Can someone help?

Thank you!!

Stijloor.
 
Q

qawatchdog

#3
I'm looking for anything more current than 2004 that speaks to IVD MDD borderline issues. We have a sterile swab used in an IVD kit that one NB says is a med device. We've tried to challenge this but so far hit a brick wall.

Thanks in advance for your input !
What kind of help are you lookig for? An argument that the sterile swab is NOT a medical device? good luck with that. Not knowing the details of where this device is marketed, indications etc., I would say it most definatly is a medical device. QAW
 
G

GPjeri

#4
I'm looking for the argument that it is NOT a med device based on my interpretation of the IVDD and the MDD.

Part 1 of my argument is.....
MEDDEV 2.14/1 states: "Mouth and other swabs having integrated reagents or reagent areas are IVD’s because their principal intended purpose is to provide information relevant to the medical purposes specified in Article 1.2 (b).

Part 2 of my argument lies in the MDD where the understanding of "purpose" and "intended purpose" comes into play, with the intended purpose being that the swab is 'part of'/to be used only with this IVD kit and not separately for any other reason.
 
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