Glossary

First-line device [MDCG 2020-16 rev.1]

MDCG

Is a device intended to be used to detect a marker or analyte  and which may be followed by a confirmatory assay. Devices intended to be used solely to monitor a previously determined marker or analyte are not considered first-line assays.

 

[Definition according to MDCG 2020-16 rev.1 No. 2]