White Paper

The Impact of New Regulations on IVD Manufacturing

Learn how the new IVDR (in vitro diagnostic regulation) rules affect future innovations


In the realm of in vitro Diagnostic (IVD) devices, the European in vitro Diagnostic Regulation (EU IVDR 2017/746) emerges as a tidal force reshaping the landscape of IVD manufacturing. 

In this white paper, Wiktoria Banczyk, MSc, product manager of Lab Filtration Medical Devices at Sartorius Lab Instruments, sheds light on the challenges and considerations that manufacturers face in the wake of this regulatory wave.

Banczyk's insights illuminate the path for manufacturers, emphasizing the need for compliance amidst intensified scrutiny. The article serves as a compass guiding manufacturers through the turbulent sea of regulations, urging them to establish robust quality management systems, invest in innovation, and forge collaborations to stay afloat in an industry evolving towards personalized medicine and digital health. This white paper discusses the extent of EU IVDR's impact, uncovering the strategic maneuvers essential for manufacturers to thrive amid the regulatory currents.

Download the white paper to learn more about: 

  • The impact of IVDR on the manufacture of IVD products

  • How to overcome new challenges to IVD product manufacturing

  • Key considerations in the design and development of an IVD product