ISO 17511: Metrological Traceability for IVD Medical Devices
Recently, a new version of ISO 17511 has been published, bringing forth updated requirements for ensuring metrological traceability in In-vitro…
EU Reference Laboratories according to IVDR
As we have already mentioned in other articles, the in-vitro diagnostic sector is undergoing to significant changes due to introduction…
Companion Diagnostic: Overview of the Regulation
According to the definition provided by European Medicine Agency (EMA), a companion diagnostic is an in-vitro diagnostic test that supports…
Analytical Performance of IVD Devices
Analytical performance for in-vitro diagnostic device is one of the main factor that need to be taken in consideration before…
Article 110 of EU IVDR 2017/746 : An Overview
In this article we will go through Article 110 of EU IVDR 2017/746. We have already been discussing about the…
Performance Evaluation Plan according to IVDR 2017/746
Performance Evaluation Plan is one of the key requirements according to IVDR 2017/746 and it is useful to define the…
ISO 23640: Stability Evaluation for IVD Medical Devices
For in-vitro diagnostic devices, ISO 23640 plays a key role as it defines the requirements related to the stability of…
IVDR 2017/746 : In Vitro Diagnostic Regulation
The IVDR – In vitro Diagnostic Regulation 2017/746 – will enter into force in 2022 but it is very important…
The New IVDR Classification for In-Vitro Diagnostic Devices
One of the biggest changes introduced with the new IVDR 2017/746 is the classification for IVD products. In fact the…
