IVDR Impact Analysis Report

Abstract

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.

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.

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Key Learning Objectives/Topics included:

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

Author(s): Dave Smart, Diaceutics, Belfast, UK, Mark Lawler, Queens University Belfast, Belfast, UK, Seamus Kearney, ARC Regulatory, Magherafelt, UK, Bastiaan Tops, Princess Maxima Children’s Centre, Utrecht, The Netherlands, Els
Wessels, Leiden University Medical Centre, Leiden, The Netherlands, Raymond Henderson, Diaceutics, Belfast, UK , Dawn Wilkinson, UK NEQAS ICC & ISH, London, UK, Piarella Peralta, Diaceutics, Belfast, UK, and contributions from the European IVDR Working Group participants, Meeting participants, affiliation, and country in Appendix I.

Year: May 2022