IVDD 98/79/EC Measuring Function Requirements

craiglab

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#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

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#3
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.
You sound right.

Cheers,
Ronen.
 
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