Molecular Health Gets IVDR Certification for Clinical Support Decision Software

Molecular Health has received EU In Vitro Diagnostics Regulation (IVDR) certification for its MH Guide clinical decision support software.

The software identifies genetic variants in solid and hematologic cancers to help physicians decide which therapies are the most promising and those that may pose an increased safety risk.

To qualify under the IVDR, the software had to meet more stringent data collection and ongoing assessment requirements as part of the EU’s increased market surveillance for potential safety risks.

Molecular Health said the software, which is used in molecular pathology laboratories, is the first of its kind in Europe to receive the certification.