IVDD 98/79/EC Measuring Function Requirements

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craiglab

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#1
#1
I am trying to understand ?device with measuring function? in IVDD 98/79/EC Annex I.B.4. My understanding is this distinction was carried in from medical device legislation and that, in general, IVDs by their general nature have a measuring function. MEDDEV 2.1/4 on this topic once was shown applicable to 98/79/EC but the current version MEDDEV 2.1/5 no longer shows 98/79/EC as related. We had a consultant some time ago rationalize that our IVD has no measuring function using 2.1/5 even though it detects a certain chemical biomarker and has a scale reading, but I don?t think his conclusion is valid. He also excluded Annex I Essential Requirements from the list of required Annexes - how can that be, short of not knowing what he's talking about?

Any insights into this aspect of the IVDD is greatly appreciated.
 
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Ronen E

Ronen E

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#3
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craiglab said:
I am trying to understand ?device with measuring function? in IVDD 98/79/EC Annex I.B.4. My understanding is this distinction was carried in from medical device legislation and that, in general, IVDs by their general nature have a measuring function. MEDDEV 2.1/4 on this topic once was shown applicable to 98/79/EC but the current version MEDDEV 2.1/5 no longer shows 98/79/EC as related. We had a consultant some time ago rationalize that our IVD has no measuring function using 2.1/5 even though it detects a certain chemical biomarker and has a scale reading, but I don?t think his conclusion is valid. He also excluded Annex I Essential Requirements from the list of required Annexes - how can that be, short of not knowing what he's talking about?

Any insights into this aspect of the IVDD is greatly appreciated.
Click to expand...
You sound right.

Cheers,
Ronen.
 
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