Recently, a new version of ISO 17511 has been published, bringing forth updated requirements for ensuring metrological traceability in In-vitro Diagnostic Medical Devices (IVDs). Within the realm of IVD devices,

As we have already mentioned in other articles, the in-vitro diagnostic sector is undergoing to significant changes due to introduction of the EU In-Vitro Diagnostic Regulation; one of these changes

According to the definition provided by European Medicine Agency (EMA), a companion diagnostic is an in-vitro diagnostic test that supports the safe and effective use of a specific medicinal product, by identifying patients that are suitable or

Analytical performance for in-vitro diagnostic device is one of the main factor that need to be taken in consideration before placing an IVD device on the market. According to IVDR

In this article we will go through Article 110 of EU IVDR 2017/746.  We have already been discussing about the requirements associated to legacy devices, specifically in the context of medical device and