Europe – IVDR : la date d’application sera-t-elle repoussée ?

Call to action to the European Commission to postpone and facilitate a phased implementation of the in vitro diagnostic Regulation

Representing cancer patients, diagnostic and laboratory industry experts and the pharmaceutical industry, we write to you with serious concerns related to the unaddressed implementation challenges faced by the healthcare sector across Europe ahead of the date of application of the In Vitro Diagnostic Regulation (IVDR). While we agree that well-regulated diagnostics are critical for patient access to high quality testing, various stakeholders within healthcare are concerned that the infrastructure supporting the transition toward a new regulatory system for diagnostics under the IVDR is not ready. Furthermore, it will not be ready on time to ensure the continued availability of tests required for patients whose conditions rely on the delivery of appropriate in vitro diagnostics…