Original from: BGI Genomics
BGI Genomics recently announced that its NIFTY® Non‑invasive Prenatal Testing (NIPT) product has obtained the CE-IVDR Certificate from TÜV SÜD Product Service GmbH (a leading global Notified Body designated under the IVDR).
The certificate (V13 125836 0004 Rev. 00) was issued following a comprehensive assessment by the Notified Body of the applicable technical documentation and quality management system requirements.
The IVDR (Regulation (EU) 2017/746) represents the European Union's most stringent regulatory framework for in vitro diagnostic medical devices, introducing significantly stringent requirements for risk-based classification, clinical evidence and performance evaluation, technical documentation, and quality management. NIPT products, which directly impact fetal health decisions, are subject to particularly rigorous scrutiny under this framework.
This achievement further demonstrates that NIFTY®'s safety, effectiveness, and quality management system have met the EU's highest regulatory. This achievement reflects BGI Genomics' unwavering commitment to quality and its position as a global leader in genomic screening technologies.
Backed by BGI Genomics’ proprietary sequencing platforms, over a decade of clinical validation, and services provided to more than 20 million families worldwide, NIFTY® has established itself as one of the most widely adopted NIPT solutions globally.
Obtaining this CE-IVDR certification further strengthens NIFTY®'s competitive position across EU Member States, the European Economic Area (EEA), and other regions where recognize or reference CE‑IVDR certification as part of local regulatory pathways – laying a solid foundation for continued international market expansion and broader accessibility of prenatal screening solutions.
BGI Genomics remains committed to scientific innovation, rigorous quality standards, and delivering safe, effective, and accessible genomic healthcare solutions to people around the world.
Source: BGI Genomics' NIFTY® Product Receives CE-IVDR Certificate
