IVD Classifications Guidance Published by GHTF

The Global Harmonization Task Force’s (GHTF) Study Group 1 has released its final guidance on classification of in vitro diagnostic (IVD) medical devices. The final version contains some minor additions but no substantive changes from the draft published in May 2007. It recommends a four-tiered, risk-based classification system specific to IVD devices. When more than one classification rule applies to an IVD device, the product is to be classified at the highest risk indicated.
The GMP Letter