# The EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) in practice: implementation and application – results of a public symposium organised by the Association of the Scientific Medical Societies in Germany (AWMF) in March 2023

## TL;DR

A webinar discussed challenges in implementing the EU's IVDR regulation for medical tests, highlighting the need for balanced approaches to ensure patient safety.

## Contribution

The paper presents insights and challenges from a public symposium on implementing the EU IVDR regulation in laboratory medicine.

## Key findings

- The IVDR implementation poses significant challenges for laboratory medicine and pathology.
- Political corrections and a balanced approach are needed to ensure patient safety without causing care gaps.

## Abstract

In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.V.) organized a full-day public webinar. Overall, it became clear that the implementation of the IVDR still poses significant challenges for laboratory medicine and pathology. Corrections at the political level and implementation with a sense of proportion are required. Before the long-term goal of the IVDR, i.e. the increase in patient safety, can be realized, the prevention of disadvantages for patients due to gaps in care must be strived for in the medium term by all parties involved.