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IVDD 98/79/EC Measuring Function Requirements
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IVDD 98/79/EC Measuring Function Requirements
IVDD 98/79/EC Measuring Function Requirements
IVDD 98/79/EC Measuring Function Requirements
IVDD 98/79/EC Measuring Function Requirements
IVDD 98/79/EC Measuring Function Requirements
IVDD 98/79/EC Measuring Function Requirements
IVDD 98/79/EC Measuring Function Requirements
IVDD 98/79/EC Measuring Function Requirements
IVDD 98/79/EC Measuring Function Requirements
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  Post Number #1  
Old 10th October 2014, 11:01 PM
craiglab

 
 
Total Posts: 24
Please Help! IVDD 98/79/EC Measuring Function Requirements

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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  Post Number #2  
Old 13th October 2014, 08:45 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,335
Re: IVDD 98/79/EC Measuring Function Requirements

A Quick Bump!

Can someone help?

If you received help here, consider helping others.

Thank you very much!!
  Post Number #3  
Old 13th October 2014, 07:24 PM
Ronen E

 
 
Total Posts: 3,736
Re: IVDD 98/79/EC Measuring Function Requirements

Quote:
In Reply to Parent Post by craiglab View Post

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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