It is often considered tricky as in what Risk Class do analysers fall, is it always Class A, are their exceptions to this. Is there a notification for guidance for this, to answer all of this the following article may guide you.
Yes the gazetted notification dated “23rd July, 2021; File No. IVD/Misc/196/2020” named as List of In-Vitro Diagnostics Medical Devices of (IVD Analysers) under provision of sub-rule (2) rule 4 of the Medical Devices Rules, 2017 ” which classifies list for the analysers in the system.
Basically you may follow the following basic understanding,All Analysers that is intended to be used for determine quantitative or qualitative measurement/concentration/values in body fluids specimen only and not near patient or subjects is falls under risk classification of Class A
All Analysers that is intended to be used for determine quantitative or qualitative measurement/concentration/values in body fluids specimen only near patient or subjects is falls under risk classification of Class B except for intended use to measure Blood Group Testing to determine ABO and Rh(D) where it will be risk classified as Class D.
