The application of the new IVDR will be mandatory for all companies effective May 26, 2022

New regulatory requirements are currently affecting the In-vitro diagnostic (IVD) industry with the transition from the In-vitro Diagnostic Directive (IVDD) to the In-vitro Diagnostic Regulation (IVDR). The application of the new IVDR will be mandatory for all companies effective May 26, 2022.

The European Union’s (EU) In-vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly impacting current processes and documentation for companies in the diagnostic market. Under this regulation, all products that stay on the market following the above-mentioned transition date, must be reassessed for IVDR compliance to ensure that they are certified for quality performance and safety purposes.

All our business units are focused on the timely implementation of the new regulation to ensure the unrestricted availability of our products in accordance with the IVDR deadline of May 26, 2022. We will continue to provide further information throughout the process.

Additional information regarding the new EU-regulation and requirements can be found on https://ec.europa.eu/health/md_sector/overview_en