Original from: Devyser

Devyser has received IVDR approval for its non-invasive fetal RHD screening product. This marks the first approval of a Class D product, the highest risk class under the new, comprehensive European regulation that came into force in May 2022. This approval confirms that Devyser’s RHD product meets the stringent safety, efficacy, and quality requirements.

"Successfully meeting the rigorous requirements for Class D certification showcases Devyser’s great organizational capabilities and underscores our strong regulatory expertise. It also reflects our commitment to providing high-quality, compliant products both in Europe and globally," says CEO Fredrik Alpsten. "National and regional screening programs present significant opportunities for Devyser RHD, one of our fastest-growing products, with an increasing number of users in Europe. We are confident that this approval will further enhance the growth potential of this product. The certification guarantees that our pioneering product continues to deliver trusted results of highest quality to clinicians and patients." 

Devyser RHD is a highly sensitive CE-IVD labelled QPCR test to conduct accurate non-invasive screening for fetal RHD that helps clinicians avoid untargeted and unnecessary treatment. 

Source: Devyser achieves Class D IVDR approval for its RHD product