This ground-breaking achievement means we comply with the IVDR (EU) 2017/746, demonstrating apDia’s commitment to designing and manufacturing truly state of the art IVD devices and proving their safety and efficacy. It is consistent with apDia’s policy to strive above all for patient safety and well-being.
Thanks to the hard work of our dedicated team, our MAIPA Assay is the first product we have released in conformity with the IVDR, and many more to follow! 🎉