Table 3.

Regulatory Demarcation of LDTs from Other Potential Health Products and as IVD Based on the Definition According to the EU IVDR.

Question 1	Is the device used in vitro for the examination of specimens derived from the human body?
Question 2	Is the device used for providing one or more of the following information?  a. concerning a physiological or pathological process or state  b. concerning congenital physical or mental impairments  c. concerning the predisposition to a medical condition or a disease  d. to determine the safety and compatibility with potential recipients  e. to predict treatment response or reactions  f. to define or monitoring therapeutic measures
Question 3	Is the device used as specimen receptacle? Note: Specimen receptacle is a device used for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination
Conditions:	Results
If both the question 1 and 2 are correct	The LDT is an IVD device
If either question 1 or question 2, and question 3 are not correct	The LDT is not an IVD device
If question 3 is correct	The LDT is an IVD device