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

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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:

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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:

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