The Global Harmonization Task Force’s (GHTF) Study Group has released its final guidance for classifying in vitro diagnostic (IVD) medical devices.
The final guidance 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 Task Force said that the purpose of the guidance is to assist manufacturers in allocating its IVD medical device to an appropriate risk class using a set of harmonized classification principles and allow regulatory authorities to rule upon matters of interpretation for a particular IVD medical device, when appropriate.
The GHTF is a voluntary consortium of representatives from medical device regulatory authorities and trade associations from around the world.