Copyright © 2020, Diaceutics. All rights reserved

Impact analysis of the IVDR on diagnostic practices & patient care across the EU: Lessons from the COVID-19 pandemic

How to Access

Introduction 

The upcoming In Vitro Diagnostics Regulation (IVDR - EU 2017/746) is currently in the process of replacing the In Vitro Diagnostics Directive (IVDD - 98/79/EC) of the European Union (EU). In this report, a specially-convened group of European laboratory stakeholders and patient advocates considers the significant implications of this change on the regulations specifically governing the development and validation of diagnostic tests in the EU.
The team of experts collaborating on this report came together in a working group (the European IVDR Working Group) in Amsterdam on the 29th of January 2020.

 . 
The Report

In the Report you’ll gain insights into the potential adverse impacts that the IVDR as currently constructed will have on diagnostic practices and subsequent patient care across the EU (as illustrated by the COVID-19 pandemic), due to the threat of significant shortage of diagnostics that comply with the regulation.

A number of recommendations provided by the European IVDR Working group to:

How to Access

Increase awareness within labs of the implications of IVDR to their test practices

Encourage individual labs to audit their test practices

Raise awareness with other stakeholders (patient advocacy groups, the pharmaceutical industry) and

Develop a network of labs/organisations to provide a unified voice for the labs to express their concerns to regulators

You will gain insights into:

DXRX - The Diagnostic Network®

An end-to-end solution for the development and commercialization of precision medicine diagnostics

Discover DXRX

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.

About Diaceutics

Access the Report on DXRX - The Diagnostic Network®

Click on any of the buttons in the information page. These will direct you to register on DXRX

Register on DXRX

Create a profile for your organization on DXRX

Login to get access to the DXRX Content Hub including IVDR Paper, and access to sponsored programs and collaborations 

For further information on how we will be capturing your personal data please see privacy statement

Need help? Email us on help@dxrx.io

Access on DXRX

How to Access