IVDR Update

May 2023

Dear Valued Customer,

As you are likely aware, the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) came into effect on May 26, 2022 to replace the current In Vitro Diagnostic Directive (IVDD). As a manufacturer of molecular diagnostic assays, we want to assure you that we are proactively working on compliance to ensure our products meet the new regulatory requirements.

The new IVDR aims to strengthen the safety and performance requirements for IVD devices, and all manufacturers must adhere to the new regulations to continue providing their products in the EU. At Asuragen, we take our commitment to quality and compliance seriously. We have been working on implementing IVDR requirements since 2020, including working with a designated Notified Body, completing gap assessments and technical documentation, and updating our quality management system documents to comply with the new regulations.

We value your business and will keep you informed of any updates related to our products. Please do not hesitate to contact us at aus.regulatory@bio-techne.com if you have any questions or concerns about IVDR as it relates to our products and services.

With Best Regards,

Mary Anne Williams
Director, Regulatory Affairs and Quality