2022/02/22 by Rabenau, Holger F., Hofmann, Jörg, Hunfeld, Klaus-Peter +4
#Medicine and health
paper · doi:10.3205/lab000044
The requirements of the new European In-Vitro Diagnostics Medical Devices Regulation (IVDR) (EU) 2017/746 is a challenge for both commercial in vitro diagnostic medical device (IVD) manufacturers and laboratories that develop and manufacture IVDs themselves (so-called Laboratory Developed Tests [LDT]). Medical laboratories in a wide range of disciplines use – often due to a lack of suitable commercially available diagnostics and to ensure patient care – in-house developed tests (LDT) or modify commercial test systems to adapt them to specific requirements (e.g. test matrix, sample volumes). These procedural instructions describe the measures that are necessary – as far as possible and indispensable – to check the performance of a test (method) that is to be newly introduced or for which a change is planned. Practical assistance is given for this purpose.