Hi Carol,
I assume you are talking about BCR/ABL1 Quant calibrators as companion products to your kits. Both calibrators and controls ARE IVDs, even is sold separately. Thus, they do require CE Marking to freely enter into commerce in the EU.
The preamble to the IVDD as amended through 18 July 2009 includes:
(9) Whereas, although internationally certified reference materials and materials used for external quality assessment schemes are not covered by this Directive, calibrators and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices;
Hope that helps.
Best regards,
Kevin
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Kevin Hawkins, RAC
Regulatory Affairs Manager
MolecularMD
Portland OR
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Original Message:
Sent: 08-14-2012 09:26
From: Carole Harris
Subject: CE marking of Calibrators for IVDs
The calibrators in question are to be sold separately from the IVD kits, and would serve as commutable secondary standards calibrated against and traceable to the WHO primary standard. The question is - do the calibrators require the CE mark to be distributed and sold in the EU? Secondly, is there any guidance available on the subject of calibrators (sold independently) used with IVDs?
Thank you,
Carole
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Carole Harris RAC
International Regulatory Program Manager
Asuragen, Inc
Austin TX
United States
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