The Impact of IVD Regulations on Manufacturing - Publication | Sartorius

Challenges in IVD Manufacturing

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The Impact of IVD Regulations on Manufacturing

Authors: Med Tec Intelligence | Last updated: March 17, 2023

Overview

IVD regulation has significant implications for the manufacturing of IVD devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Wiktoria Banczyk, Product Manager Lab Filtration Medical Devices at Sartorius Lab Instruments, discusses the challenges posed by the implementation of EU IVDR 2017/746 and key considerations for manufacturers as they navigate today’s regulatory landscape.

Read the interview now and find out why the impact of IVD regulations can’t be overstated and how manufacturers of IVD products can overcome the challenges.


  • Document type: Publication
  • Page count: 5
  • Read time: 6 minutes


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Key Takeaways

  • In vitro diagnostic (IVD) devices are used to perform tests on human specimens such as urine, blood, or tissue, to help diagnose diseases or monitor health conditions. 
  • The IVD industry is expected to evolve rapidly in the coming years.
  • Manufacturers will need to adapt to these changes and invest in research and development to develop new products and technologies that meet customer needs and ensure compliance with IVD regulations.

This Resource is Designed for:

  • Manufacturers of IVD products
  • Lab Researchers
  • Lab Technicians
  • Medical Devices Manufacturers
  • Scientists
  • Engineers
  • Lab Post Doc
  • Analytical Lab Assistants

Applications Supported:

  • In vitro diagnostic (IVD)

  • Healthcare

  • Medicine

  • Clinical studies

  • Patient health and clinical decision-making

  • Concentration and filtration of proteins and macromolecules

  • Analysis of biomarkers


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