Devyser’s quality management system and fetal diagnostics product approved under the new European IVD Regulation
Devyser has today been certified under the new, more comprehensive IVD Regulation that came into force on May 26, 2022. The certification, issued by the notified body TÜV SÜD, covers Devyser’s quality management system and fetal diagnostics product. The approval strengthens Devyser’s position in the market and confirms the company’s long-term focus on quality and patient safety. From May 26, 2022, all new medical devices to be sold in Europe will have to comply with the new IVD Regulation that defines enhanced quality and safety requirements for diagnostic use of medical devices to