In case you missed it, the MDCG quietly updated the 2020-16
Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. In the
January 2022 revision 1 update, they moved “erythrocyte sedimentation rate analyser” from the list of examples for Rule 5(b) to the statement within the text discussion where they mention exemptions from the rule that should be classified according to the intended purpose of the analysis. The updated guidance appears to correct an error that initially indicated that erythrocyte sedimentation rate (ESR) analysers were a specific example of the allowance provided by Rule 5(b) to simply classify instruments as class A devices where these are used in combination with reagents to produce test results.
The intent of Rule 5(b) is to allow for in vitro diagnostic (IVD) instruments, or analysers, that are used in combination with IVD reagents to produce test results to be classified at a lower risk than the reagents. This approach acknowledges that the IVD reagents are the critical components in an IVD test. However, most, if not all, ESR analysers directly measure and report the ESR in whole blood without the use of reagents. Because an increased sedimentation rate can indicate tissue damage or inflammation, the result provided by the ESR analyser directly from a patient sample without the use of reagents can be used for patient management. Thus, the classification for an ESR analyser should be made according to the intended purpose of the analysis provided by the analyser instead of using the blanket classification of class A provided by Rule 5(b).
In conclusion, the updated MDCG 2020-16 rev. 1 corrects an apparent error in the original guidance and clarifies that IVD instruments used in combination with IVD reagents to produce test results are class A, and IVD instruments that provide results from independent measuring functions without the use of reagents must be classified in their own right according to the intended purpose of the analysis.