Making sense of IVDR for LC-MS

In this whitepaper, Tecan provides information on how to interpret and prepare for the In Vitro Diagnostic Regulation (IVDR) on laboratory developed tests (LDTs) in mass spectrometry (MS). The IVDR is Europe’s set of rules designed to improve the quality, safety, and reliability of in vitro diagnostics (IVDs). Although the IVDR is largely targeted at manufacturers, this regulation also puts a higher burden on clinical labs, especially those doing liquid chromatography–mass spectrometry (LC-MS), because it has implications for the use of LDTs, in-house devices or ‘home-brew’ methods. Even if the tests are being run in non-EU labs, the IVDR may still apply if the samples being tested are from European citizens.