In December 2020, MDA published the 2nd edition of the guidance document on the classification system of in-vitro diagnostic (IVD) medical devices. There are no major differences between the 1st and 2nd editions of the guidance documents. There is a more solid and structured explanation for each classification. The improved definition of IVD medical device is included in Section 4.5 IVD medical device while the definition of IVD analyzer is added in Section 4.8 IVD analyzer. There are three types of system analyzer included, i.e.:

1. Closed system analyzer,

2. Open system analyzer,

3. Partially closed system analyzer.

Furthermore, more explanations and examples of the medical device are included in the updated guidance documents. It also now has more information on the application of the rationale rule. This additional information is useful and can help establish to classify IVD medical devices more accurately.



MDA/GD/0001 In Vitro Diagnostic (IVD) Medical Device Classification System